Data / Medical devices / United States / Beckman Coulter, Inc.
Beckman Coulter, Inc.: FDA-registered device maker in Brea, CA, United States, 118 510(k) clearances
Beckman Coulter, Inc. is registered with the FDA (registration 2050012) in Brea, CA, United States. It lists 128 device types. The FDA files 118 510(k) clearances under its listings, the newest dated January 16, 2019. 356 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2050012
- Address
- 250 S Kraemer Blvd, Brea, CA, United States, 92821
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 16, 1977
- Registered through
- 2026
- Brand names listed
- 378020 High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200), 378045 SYNCHRON Systems Vancomycin Calibrator, 378194 Salicylate Reagent (SALY 2 x 45), 439715 Direct Bilirubin Reagent (DBIL 2 x 200), 439770 Ammonia Reagent (AMM 2 x 25), 441350 SYNCHRON Systems Enzyme Validator Set Levels 1 & 2, 441470 Immunochemistry Systems UCAL Urine Protein Calibrator, 442600 SYNCHRON Systems SYNCHRON Multi Calibrator and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 118.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 16, 2019 | K182651 | HbA1c Advanced | PDJ | Substantially Equivalent | Beckman Coulter Ireland, Inc. | accessdata.fda.gov |
| February 26, 2015 | K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | JIT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 14, 2014 | K140829 | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT | LCP | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 17, 2014 | K131189 | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) | CFR | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 7, 2014 | K130122 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER | CFN | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| October 12, 2012 | K120199 | GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY | LCP | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| September 11, 2012 | K121492 | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT | LCP | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| May 25, 2011 | K110251 | SYNCHRON MULTI CALIBRATOR | JIX | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 27, 2011 | K103842 | UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 | CGA | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 7, 2011 | K103373 | SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 | DIH | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 4, 2009 | K093458 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | JFY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| October 16, 2009 | K091846 | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 | JFJ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| August 14, 2009 | K091742 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | JFY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 8, 2009 | K082251 | SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 | DCF | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| June 21, 2007 | K071002 | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT | NQD | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| June 1, 2007 | K071283 | SYNCHRON SYSTEMS CREATININE REAGENT | CGX | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| June 1, 2007 | K071280 | SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | CGX | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| June 1, 2007 | K071277 | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | CGX | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| May 4, 2007 | K070626 | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT | NQD | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 27, 2006 | K060256 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM | CFR | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 13, 2006 | K060130 | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT | CZP | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 16, 2005 | K053090 | DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR | JFM | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 28, 2005 | K043556 | SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT | JXM | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| November 12, 2004 | K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS | CEM | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| August 18, 2004 | K041643 | SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT | CEO | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| August 18, 2003 | K032287 | MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 | JIX | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| August 7, 2003 | K032035 | SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI | CZW | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 15, 2003 | K031870 | SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT | LEG | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 24, 2003 | K024210 | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR | DGC | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 19, 2002 | K021572 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR | DCN | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 15, 2002 | K014173 | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR | DKJ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 15, 2002 | K013978 | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT | JFJ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 12, 2001 | K013076 | SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR | LEH | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| June 8, 2001 | K011465 | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO | LDP | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 5, 2001 | K010236 | IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT | DCK | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 5, 2001 | K010358 | VIGIL SEROLOGY CONTROL LEVEL C | JJY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| November 27, 2000 | K003488 | SYNCHRON CONTROL | JJY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| May 17, 2000 | K000121 | IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB | DFC | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| May 5, 2000 | K000606 | SYNCHRON SYSTEMS AMPHETAMINE REAGENT | DKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 14, 2000 | K000494 | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT | LDP | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 10, 2000 | K000410 | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS | DMT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 10, 2000 | K000331 | SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR | JIS | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 3, 2000 | K994168 | SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR | JIS | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 1, 2000 | K993547 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB | CFN | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 11, 2000 | K993954 | SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS | DKB | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| November 26, 1999 | K993473 | SYNCHRON SYSTEMS DRUG CALIBRATOR 2 | DLJ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| November 26, 1999 | K993023 | SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS | JJY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| November 9, 1999 | K993022 | SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS | DLJ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 29, 1999 | K984402 | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT | JIF | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 29, 1999 | K984152 | SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT | DJG | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 21, 1998 | K983640 | SYNCHRON SYSTEMS LIPID CALIBRATOR | JIS | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 14, 1998 | K983340 | IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR | DBF | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| October 28, 1998 | K983709 | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 | DIF | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| October 14, 1998 | K982935 | SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR | KXT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 9, 1998 | K982224 | VIGIL PROTEIN CONTROL | JJY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 6, 1998 | K982022 | VIGIL HEMOGLOBIN (HBALC) CONTROLS | JJX | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| June 12, 1998 | K981638 | IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT | DCK | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 17, 1998 | K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | DEB | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| December 24, 1997 | K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | JBQ | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| December 17, 1997 | K974452 | VIGIL LIPID CONTROL | JJY | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| December 15, 1997 | K973932 | BECKMAN CALIBRATOR 2 (CAL2) | JIX | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| December 1, 1997 | K973928 | BECKMAN URINE PROTEIN CALIBRATOR (UCAL) | JIX | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| November 24, 1997 | K974050 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT | DCK | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| September 22, 1997 | K973069 | SYNCHRON SYSTEMS METHADONE REAGENT | DJR | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| August 20, 1997 | K971958 | SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT | DDG | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| August 13, 1997 | K972819 | VIGIL TDM CONTROLS | DIF | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| June 11, 1997 | K964842 | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT | CZW | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| June 3, 1997 | K971283 | SYNCHRON SYSTEMS CAL 5 PLUS | JIX | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| May 23, 1997 | K971333 | SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD | JIX | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| May 21, 1997 | K971534 | SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL | DIF | Substantially Equivalent | Beckman | accessdata.fda.gov |
| May 21, 1997 | K970919 | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT | KNK | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| May 9, 1997 | K964781 | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT | DDS | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| May 8, 1997 | K971287 | SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS | DKB | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| April 29, 1997 | K964695 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT | DCF | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| April 25, 1997 | K964766 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) | DEM | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| April 25, 1997 | K964762 | IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT | DDB | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| April 21, 1997 | K970314 | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS | MSJ | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| April 21, 1997 | K965033 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT | MGA | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| April 17, 1997 | K971210 | SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS | LAS | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| April 17, 1997 | K965035 | IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT | JIQ | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| March 24, 1997 | K964257 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | LKL | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| March 19, 1997 | K963976 | IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT | DDG | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| March 10, 1997 | K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L | JJE | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| March 6, 1997 | K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT | DEW | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| March 6, 1997 | K964843 | IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT | JZH | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| March 6, 1997 | K963974 | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN | DEW | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| February 10, 1997 | K964260 | IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG | DFH | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| February 10, 1997 | K964010 | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT | MSJ | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| February 10, 1997 | K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) | DEW | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| November 4, 1996 | K963048 | IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT | DHR | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| October 7, 1996 | K963427 | IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT | DDG | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| October 7, 1996 | K963286 | IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT | DAD | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| August 21, 1996 | K962294 | IMMAGE IMMUNOCHEMISTRY SYSTEM | JQX | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| May 10, 1996 | K960485 | SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS | JMO | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| April 3, 1996 | K955677 | SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT | LDJ | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| February 16, 1996 | K955644 | SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM | KLT | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| February 9, 1996 | K955675 | SYNCHRON SYSTEMS PROPOXYPHENE REAGENT | JXN | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| October 3, 1995 | K953979 | APOLIPOPROTEIN CALIBRATOR (APO-CAL) | JIX | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| September 21, 1995 | K952427 | CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE | CKA | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
| May 15, 1995 | K951635 | BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL | DEW | Substantially Equivalent | Beckman Instruments, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 356.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 2, 2026 | 99800 | Class II | Ongoing | DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252 | Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to reve | accessdata.fda.gov |
| July 15, 2026 | 99436 | Class II | Ongoing | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, Dx | a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test resul | accessdata.fda.gov |
| June 26, 2026 | 99349 | Class II | Ongoing | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 Micr | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." | accessdata.fda.gov |
| September 22, 2025 | 97624 | Class II | Ongoing | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using | Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results. | accessdata.fda.gov |
| September 17, 2025 | 97628 | Class II | Ongoing | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 | Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter. | accessdata.fda.gov |
| September 3, 2025 | 97590 | Class II | Ongoing | SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only. | Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results. | accessdata.fda.gov |
| August 13, 2025 | 97464 | Class II | Ongoing | UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. | accessdata.fda.gov |
| August 4, 2025 | 97390 | Class II | Ongoing | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer | On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays. | accessdata.fda.gov |
| June 26, 2025 | 97178 | Class II | Ongoing | UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205 | Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemol | accessdata.fda.gov |
| June 12, 2025 | 97132 | Class II | Ongoing | Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma. | A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits. | accessdata.fda.gov |
| April 8, 2025 | 96685 | Class II | Ongoing | REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Mana | Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are | accessdata.fda.gov |
| March 20, 2025 | 96512 | Class II | Ongoing | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measu | Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able t | accessdata.fda.gov |
| March 17, 2025 | 96483 | Class II | Ongoing | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry A | The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results. | accessdata.fda.gov |
| February 26, 2025 | 96430 | Class II | Ongoing | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measur | Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated | accessdata.fda.gov |
| January 2, 2025 | 96089 | Class II | Ongoing | Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems | Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve. | accessdata.fda.gov |
| November 8, 2024 | 95738 | Class II | Ongoing | Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma. | The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or | accessdata.fda.gov |
| July 31, 2024 | 95285 | Class II | Ongoing | IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunog | Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU | accessdata.fda.gov |
| May 27, 2024 | 94787 | Class II | Ongoing | Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 | LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal | accessdata.fda.gov |
| July 12, 2023 | 92729 | Class II | Ongoing | Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 | Lipemic interference failed to meet the performance specification listed within the IFU. | accessdata.fda.gov |
| April 5, 2023 | 92071 | Class II | Ongoing | Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. | accessdata.fda.gov |
| December 8, 2021 | 89178 | Class II | Terminated | AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 | Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia. | accessdata.fda.gov |
| November 10, 2021 | 89035 | Class II | Ongoing | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 | Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol pati | accessdata.fda.gov |
| August 9, 2021 | 88559 | Class II | Ongoing | Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK | Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the pro | accessdata.fda.gov |
| August 5, 2021 | 88612 | Class II | Terminated | Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341 | Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute | accessdata.fda.gov |
| July 28, 2021 | 88615 | Class II | Ongoing | Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116 | Missing splash guard which may expose users to hazardous materials.. | accessdata.fda.gov |
| July 21, 2021 | 88519 | Class II | Terminated | DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118 | There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs | accessdata.fda.gov |
| July 15, 2021 | 88339 | Class II | Terminated | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. | There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result. | accessdata.fda.gov |
| July 1, 2021 | 88261 | Class II | Terminated | ACCESS SARS-CoV-2 Antigen, REF: C68668, IVD, Rx only, UDI: (01) 15099590742713 | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis. | accessdata.fda.gov |
| May 7, 2021 | 87960 | Class II | Terminated | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values. | accessdata.fda.gov |
| April 14, 2021 | 87738 | Class II | Terminated | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e | specimens collected in transport media may result is false negative results when stored in certain conditions. | accessdata.fda.gov |
| December 30, 2020 | 87146 | Class II | Terminated | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only. | The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC. | accessdata.fda.gov |
| December 2, 2020 | 86817 | Class II | Terminated | MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some | Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification. | accessdata.fda.gov |
| August 26, 2020 | 86386 | Class II | Terminated | BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570. | Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. | accessdata.fda.gov |
| August 18, 2020 | 86273 | Class II | Terminated | UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in hu | The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range. | accessdata.fda.gov |
| March 30, 2020 | 85423 | Class II | Terminated | iChemVELOCITY Urine Chemistry System- | A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM. | accessdata.fda.gov |
| January 29, 2020 | 85467 | Class II | Terminated | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma. | Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with changes in the body acid-base balance, has a low pH and may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results which can lea | accessdata.fda.gov |
| January 17, 2020 | 85048 | Class II | Terminated | LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimic | A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that Data Management System computers would not restart. If the computer is unable to restart, then the system cannot download data generated from MicroScan instruments or manually ent | accessdata.fda.gov |
| December 13, 2019 | 85137 | Class II | Terminated | Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial suscept | Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results. | accessdata.fda.gov |
| November 7, 2019 | 84268 | Class II | Terminated | iChem VELOCITY Urine Chemistry Analyzer | Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results. | accessdata.fda.gov |
| October 28, 2019 | 84577 | Class II | Terminated | iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. | Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics). | accessdata.fda.gov |
| October 21, 2019 | 90087 | Class II | Ongoing | MicroScan WalkAway-40 plus Instrument REF B1018-283 | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere | accessdata.fda.gov |
| September 4, 2019 | 87486 | Class II | Terminated | MicroScan WalkAway-40 plus Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure. | accessdata.fda.gov |
| September 4, 2019 | 85289 | Class II | Terminated | Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides | Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results. | accessdata.fda.gov |
| June 12, 2019 | 85140 | Class II | Terminated | SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators | The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results. | accessdata.fda.gov |
| May 17, 2019 | 84918 | Class II | Terminated | Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352. | Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing. | accessdata.fda.gov |
| April 30, 2019 | 84862 | Class II | Terminated | Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,2 | accessdata.fda.gov |
| December 5, 2018 | 82079 | Class II | Ongoing | The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84 | When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to | accessdata.fda.gov |
| November 9, 2018 | 83732 | Class II | Ongoing | AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083, Model #ODL25255 | Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS). | accessdata.fda.gov |
| October 18, 2018 | 82879 | Class II | Terminated | iChem VELOCITY Urine Chemistry Strips, REF, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany. | Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction. | accessdata.fda.gov |
| September 18, 2018 | 83163 | Class II | Terminated | The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanita | Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%). | accessdata.fda.gov |
| September 17, 2018 | 82919 | Class II | Terminated | Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kal | Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results. | accessdata.fda.gov |
| August 24, 2018 | 83583 | Class II | Terminated | Beckman Coulter Lipase, REF OSR6130 and OSR6230. | NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. | accessdata.fda.gov |
| July 30, 2018 | 82329 | Class I | Terminated | UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer | Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. | accessdata.fda.gov |
| May 24, 2018 | 80434 | Class III | Terminated | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. Sorting Drive software version 4.2 was replaced by 4.2.1 (both versions contain the same option for manual barcode printing). When printing consecutively numbered tube labels using this opti | accessdata.fda.gov |
| May 4, 2018 | 80330 | Class II | Terminated | MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive coc | The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported. | accessdata.fda.gov |
| March 29, 2018 | 79895 | Class II | Terminated | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in- | The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity. | accessdata.fda.gov |
| March 26, 2018 | 79800 | Class II | Terminated | BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroSca | Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimicrobial agents Cefaclor (Ctr) and Penicillin (P) with control organism Streptococcus pneumoniae (ATCC 49619) during quality control (QC) testing on MICroSTREP plus(R) Panel Type 1 hydrated with Mueller-Hinton Broth with 3% lysed horse blood part numbe | accessdata.fda.gov |
| March 2, 2018 | 79575 | Class II | Terminated | BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers:,,,, 800- 7106,,,,,,,,, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic devic | Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from thos | accessdata.fda.gov |
| March 2, 2018 | 79566 | Class II | Terminated | BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers:, C10684,, C10683 | Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method | accessdata.fda.gov |
| January 29, 2018 | 79381 | Class II | Terminated | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co | The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification. | accessdata.fda.gov |
| January 19, 2018 | 79006 | Class II | Completed | AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255 | Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination. | accessdata.fda.gov |
| January 18, 2018 | 78999 | Class II | Terminated | AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system. | A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips. | accessdata.fda.gov |
| January 12, 2018 | 81039 | Class I | Terminated | 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application. | accessdata.fda.gov |
| December 4, 2017 | 79857 | Class II | Terminated | iChem VELOCITY Urine Chemistry Strips, REF Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Uri | A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes. | accessdata.fda.gov |
| November 10, 2017 | 79368 | Class II | Terminated | iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: | iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria. | accessdata.fda.gov |
| November 6, 2017 | 78613 | Class III | Terminated | Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. | accessdata.fda.gov |
| November 3, 2017 | 78611 | Class II | Terminated | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. | accessdata.fda.gov |
| October 2, 2017 | 78256 | Class II | Terminated | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotypi | The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS) | accessdata.fda.gov |
| August 24, 2017 | 78699 | Class II | Terminated | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Che | Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. QC failures could occur if inc | accessdata.fda.gov |
| August 21, 2017 | 77997 | Class II | Terminated | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. | Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples. | accessdata.fda.gov |
| August 3, 2017 | 77982 | Class II | Terminated | Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation. | Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process, which should not occur. This issue and associated complaint were discovered and filed internally. | accessdata.fda.gov |
| July 20, 2017 | 77896 | Class II | Terminated | Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K, Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testi | Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification. | accessdata.fda.gov |
| June 26, 2017 | 77830 | Class II | Terminated | Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples. | accessdata.fda.gov |
| June 20, 2017 | 77778 | Class II | Terminated | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood sm | The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation. | accessdata.fda.gov |
| May 22, 2017 | 77362 | Class II | Terminated | Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirat | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run. | accessdata.fda.gov |
| May 15, 2017 | 77364 | Class II | Terminated | Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems. | The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1. | accessdata.fda.gov |
| May 9, 2017 | 77245 | Class II | Terminated | Access Total T3, A34435H, Catalog No. 33830 | The Access immunoassays are susceptible to biotin interference. | accessdata.fda.gov |
| April 24, 2017 | 77145 | Class II | Terminated | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322. | There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result. | accessdata.fda.gov |
| April 24, 2017 | 77138 | Class II | Terminated | Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems MA Calibrator, is intended for quantitative determination of | Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1. | accessdata.fda.gov |
| April 13, 2017 | 77029 | Class II | Terminated | Access BR Monitor, Part No. 387620 | Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de scurit du Medicament et des produits de sant (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper ref | accessdata.fda.gov |
| April 3, 2017 | 76962 | Class II | Terminated | Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF). | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results. | accessdata.fda.gov |
| April 3, 2017 | 76961 | Class II | Terminated | AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent | Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files. | accessdata.fda.gov |
| March 10, 2017 | 76838 | Class II | Terminated | Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C | Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration. | accessdata.fda.gov |
| March 7, 2017 | 76688 | Class II | Terminated | Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determinatio | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process. | accessdata.fda.gov |
| February 13, 2017 | 76486 | Class II | Terminated | Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in s | Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match. | accessdata.fda.gov |
| January 30, 2017 | 76374 | Class II | Terminated | iChemVELOCITY Urine Chemistry System, Catalog No.,,,,,,,,,,,. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilin | The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results. | accessdata.fda.gov |
| December 21, 2016 | 76054 | Class III | Terminated | AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample | Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10. | accessdata.fda.gov |
| December 19, 2016 | 76044 | Class II | Terminated | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304 | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations. | accessdata.fda.gov |
| October 25, 2016 | 75576 | Class II | Terminated | MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiolo | Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels. | accessdata.fda.gov |
| October 24, 2016 | 75526 | Class II | Terminated | Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) le | Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria. | accessdata.fda.gov |
| October 19, 2016 | 75503 | Class II | Terminated | AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole b | Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application. The issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. Depending on the | accessdata.fda.gov |
| September 6, 2016 | 75111 | Class II | Terminated | AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels. | Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. | accessdata.fda.gov |
| August 8, 2016 | 74912 | Class II | Terminated | UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis Syste | There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID. | accessdata.fda.gov |
| August 4, 2016 | 74875 | Class II | Terminated | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated s | Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire. | accessdata.fda.gov |
| June 27, 2016 | 74559 | Class II | Terminated | The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall. | Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery. | accessdata.fda.gov |
| June 8, 2016 | 74393 | Class II | Terminated | Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using th | Demonstrate an upward shift in patient results. | accessdata.fda.gov |
| May 17, 2016 | 74212 | Class II | Terminated | Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human | Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of pat | accessdata.fda.gov |
| April 13, 2016 | 73921 | Class II | Terminated | Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers. | Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. | accessdata.fda.gov |
| February 11, 2016 | 73417 | Class II | Terminated | MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000 | Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status. | accessdata.fda.gov |
| February 5, 2016 | 74567 | Class II | Terminated | Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components | A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration. | accessdata.fda.gov |
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Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.