Data / Medical devices / United States / Abbott Laboratories
Abbott Laboratories: FDA-registered device maker in Abbott Park, IL, United States, 11 510(k) clearances
Abbott Laboratories is registered with the FDA (registration 1415939) in Abbott Park, IL, United States. It lists 16 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 15, 2019. 85 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1415939
- Address
- 100 Abbott Park RD., Abbott Park, IL, United States, 60064
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 13, 1977
- Registered through
- 2027
- Brand names listed
- ACE Calibrator (LN 06U8201), ACE Calibrator (LN 06U8601), ACE Control (LN 06U8210), ACE Control (LN 06U8610), ARCHITECT 2nd Generation Testosterone Calibrators (LN 2P13-01), ARCHITECT 2nd Generation Testosterone Controls (LN 2P13-10), ARCHITECT 2nd Generation Testosterone Reagent Kit (LN 2P13-27), ARCHITECT Cyclosporine Calibrators - LN 01L7501 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 15, 2019 | K190294 | CELL-DYN Emerald 22 AL System | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 23, 2017 | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | DHA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 19, 2017 | K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | CFR | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 28, 2016 | K151502 | ARCHITECT ROMA | ONX | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
| December 17, 2015 | K152155 | ARCHITECT 2nd Generation Testosterone | CDZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| September 11, 2012 | K120009 | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) | CDZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 22, 2011 | K110381 | CELL-DYN EMERALD 22 SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 4, 2009 | K081495 | CELL-DYN EMERALD SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| September 11, 2008 | K080751 | ARCHITECT CYCLOSPORINE | MKW | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
| September 28, 2007 | K070822 | ARCHITECT SIROLIMUS ASSAY | NRP | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
| August 1, 2007 | K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 | MLM | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 18, 2025 | 96567 | Class II | Ongoing | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual. | accessdata.fda.gov |
| February 21, 2024 | 94149 | Class II | Ongoing | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction. | accessdata.fda.gov |
| October 19, 2023 | 93349 | Class II | Ongoing | Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer. | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | accessdata.fda.gov |
| July 26, 2022 | 90692 | Class II | Ongoing | ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. | accessdata.fda.gov |
| March 8, 2022 | 89794 | Class II | Ongoing | ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of my | This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU). | accessdata.fda.gov |
| April 1, 2020 | 85394 | Class III | Terminated | ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained. | accessdata.fda.gov |
| May 24, 2019 | 83053 | Class III | Terminated | ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. | accessdata.fda.gov |
| April 9, 2019 | 82590 | Class III | Terminated | ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood. | Devices were delivered without the required dry ice. | accessdata.fda.gov |
| April 18, 2017 | 77070 | Class II | Terminated | ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT | Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type. | accessdata.fda.gov |
| October 11, 2016 | 75448 | Class II | Terminated | ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma. | Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21). | accessdata.fda.gov |
| March 24, 2016 | 73826 | Class II | Terminated | The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma. | Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant. | accessdata.fda.gov |
| June 11, 2015 | 71473 | Class II | Terminated | ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potenti | The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak. | accessdata.fda.gov |
| May 11, 2015 | 71244 | Class II | Terminated | Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is ship | The product is leaking from the cap and crystallization was noted as present around the cap. | accessdata.fda.gov |
| July 22, 2014 | 71302 | Class II | Terminated | ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays. | ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem. | accessdata.fda.gov |
| April 30, 2014 | 68201 | Class II | Terminated | HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the ca | HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated. | accessdata.fda.gov |
| February 12, 2014 | 67527 | Class II | Terminated | ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane bu | Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. The issue may also impact your established ARCHITECT Intact P | accessdata.fda.gov |
| December 12, 2012 | 63912 | Class II | Terminated | Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic. | The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels. | accessdata.fda.gov |
| May 30, 2012 | 61979 | Class II | Terminated | ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoass | The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range. | accessdata.fda.gov |
| April 11, 2012 | 61630 | Not yet classified | Terminated | ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL | The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to kit. A concentration change of up to +/-55% could occur when switching kits without recalibrating. | accessdata.fda.gov |
| October 7, 2011 | 60094 | Not yet classified | Terminated | ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Div | The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision. | accessdata.fda.gov |
| July 11, 2011 | 59335 | Not yet classified | Terminated | ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08 | C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls. | accessdata.fda.gov |
| April 20, 2011 | 58591 | Not yet classified | Terminated | ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipota | The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results. | accessdata.fda.gov |
| September 13, 2010 | 56757 | Not yet classified | Terminated | ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability | The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment. | accessdata.fda.gov |
| September 7, 2010 | 56719 | Not yet classified | Terminated | Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood; Abbott Laboratories, Abbott Diagnostics Di | There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode. | accessdata.fda.gov |
| May 27, 2010 | 55871 | Not yet classified | Terminated | Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Di | The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors. | accessdata.fda.gov |
| April 30, 2010 | 55557 | Not yet classified | Terminated | IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl | IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors. | accessdata.fda.gov |
| April 24, 2009 | 51928 | Not yet classified | Terminated | ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott Laboratories, Diagnos | There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-27) due to the use of assay disk versions that do not contain the updated ARCHITECT LH assay file contained on ARCHITECT i System Assay CD ROM versions 24 and higher (US LN 6E58, WW LN 6E59). | accessdata.fda.gov |
| February 26, 2009 | 51254 | Not yet classified | Terminated | ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list 7C15-01. The ARCHITECT Reaction Vessels are disposable container | Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of ARCHITECT Reaction Vessels. | accessdata.fda.gov |
| February 20, 2009 | 51275 | Not yet classified | Terminated | Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05. AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for t | The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution protocol the instrument to report results between 0 ng/mL and 0.4 ng/mL (40.4 ng/mL accounting for the 1:101 dilution). The sensitivity of the assay is 0.4 ng/mL. | accessdata.fda.gov |
| February 18, 2009 | 51258 | Not yet classified | Terminated | AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09. To be used only for cleaning and inhibition of fouling bacteria in the | Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date. | accessdata.fda.gov |
| January 19, 2009 | 50816 | Not yet classified | Terminated | AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal ser | Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument. | accessdata.fda.gov |
| September 5, 2008 | 49427 | Not yet classified | Terminated | Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck | The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do not perform as intended, the integrity of the system cannot be verified and patient results would not be generated. Other commercially available materials are available to customers in order to meet CLIA requirements. | accessdata.fda.gov |
| June 16, 2008 | 48701 | Not yet classified | Terminated | ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatical | When running the Automated Dilution Protocol with the assay files "CMV IgG" or "Toxo IgG" on the ARCHITECT i1000SR system, a software error [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops running. No results are generated. | accessdata.fda.gov |
| June 2, 2008 | 48626 | Not yet classified | Terminated | AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG an | An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high. | accessdata.fda.gov |
| February 27, 2008 | 47236 | Not yet classified | Terminated | Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05. Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott AR | Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees Celsius through expiration dating. These lots may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification s | accessdata.fda.gov |
| January 21, 2008 | 46740 | Not yet classified | Terminated | AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064 | Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result. | accessdata.fda.gov |
| October 1, 2007 | 45395 | Not yet classified | Terminated | Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs); Abbott Laboratories, Abbott Park, IL 60064 | Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens. | accessdata.fda.gov |
| September 18, 2007 | 45397 | Not yet classified | Terminated | ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA | The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL | accessdata.fda.gov |
| July 6, 2007 | 38439 | Not yet classified | Terminated | ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of | The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual. | accessdata.fda.gov |
| April 23, 2007 | 37887 | Not yet classified | Terminated | AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument. | accessdata.fda.gov |
| March 8, 2007 | 37570 | Not yet classified | Terminated | ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, A | False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less than 0.1 ng/mL | accessdata.fda.gov |
| February 19, 2007 | 37446 | Not yet classified | Terminated | ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Labo | A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each. | accessdata.fda.gov |
| January 2, 2007 | 37070 | Not yet classified | Terminated | ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21 | The ARCHITECT AUSAB and ARCHITECT Anti-HCV assay parameter default interpretation screens when using ARCHITECT Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the ARCHITECT AUSAB Reagent Package Insert (PI) 34-4162/R1 and ARCHITECT Anti-HCV PI 34-4152/R1. | accessdata.fda.gov |
| November 22, 2006 | 36889 | Not yet classified | Terminated | ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 ( | The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been o | accessdata.fda.gov |
| August 11, 2006 | 37002 | Not yet classified | Terminated | IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methy | The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens. | accessdata.fda.gov |
| June 9, 2006 | 35627 | Not yet classified | Terminated | CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRI | The CA 15-3 Controls replicates out of range high resulting in invalid runs. | accessdata.fda.gov |
| June 6, 2006 | 35612 | Not yet classified | Terminated | ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA | Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2). | accessdata.fda.gov |
| March 8, 2006 | 34923 | Not yet classified | Terminated | ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Ab | The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument. | accessdata.fda.gov |
| December 21, 2005 | 34297 | Not yet classified | Terminated | ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 | There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors. | accessdata.fda.gov |
| October 17, 2005 | 33845 | Not yet classified | Terminated | ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 | Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen. | accessdata.fda.gov |
| August 7, 2005 | 32895 | Not yet classified | Terminated | ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Abbott Park, IL 60064 | False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control. | accessdata.fda.gov |
| June 27, 2005 | 32540 | Not yet classified | Terminated | XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA | The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay. | accessdata.fda.gov |
| March 16, 2005 | 31466 | Not yet classified | Terminated | ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, | False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control. | accessdata.fda.gov |
| March 11, 2005 | 31410 | Not yet classified | Terminated | ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A. | concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert. | accessdata.fda.gov |
| September 1, 2004 | 29957 | Not yet classified | Terminated | XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Sodium Azide as a preservative; 950 mL bottle, 4 bottles per carton; Abbott Laboratories, Abbott | The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines assay can cause shifts in control values and patient results. | accessdata.fda.gov |
| August 27, 2004 | 29922 | Not yet classified | Terminated | Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 | There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots. | accessdata.fda.gov |
| August 19, 2004 | 29911 | Not yet classified | Terminated | ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany | Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration of the reagents. | accessdata.fda.gov |
| June 11, 2004 | 29352 | Not yet classified | Terminated | ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA | False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control. | accessdata.fda.gov |
| March 26, 2004 | 28649 | Not yet classified | Terminated | AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 | An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction. | accessdata.fda.gov |
| March 23, 2004 | 28641 | Not yet classified | Terminated | ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A. | The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents. | accessdata.fda.gov |
| February 16, 2004 | 28342 | Not yet classified | Terminated | TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 | The package inserts contain incorrect control values for the urinary free cortisol extraction procedure. | accessdata.fda.gov |
| December 17, 2003 | 28167 | Not yet classified | Terminated | 18 Gauge thin wall needle as part of a Central Venous Catheter Kit | 18 gauge needles in Central Venous Catheter kits may be partially occluded. | accessdata.fda.gov |
| December 16, 2003 | 27978 | Not yet classified | Terminated | ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA | The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results. | accessdata.fda.gov |
| December 15, 2003 | 27977 | Not yet classified | Terminated | ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064 | The calibrator lots may yield Free T4 values that are depressed. | accessdata.fda.gov |
| December 5, 2003 | 27971 | Not yet classified | Terminated | TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 | The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table | accessdata.fda.gov |
| December 2, 2003 | 27898 | Not yet classified | Terminated | Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064 | The Operations Manual has the wrong Farenheit temperature range listed ) instead of ) for the preparation of the Terg-A-Zyme solution used to clean pipettes of the Abbott Commander Flexible Pipetting Center. | accessdata.fda.gov |
| November 25, 2003 | 27834 | Not yet classified | Terminated | AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064 | The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4 | accessdata.fda.gov |
| November 23, 2003 | 27835 | Not yet classified | Terminated | IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA | Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing IMx Folate testing. | accessdata.fda.gov |
| November 19, 2003 | 27788 | Not yet classified | Terminated | Pentalumen TD Thermodilution Catheter, Sterile | Thermodilution catheters have a potential for ruptured lumens within the catheter. | accessdata.fda.gov |
| November 17, 2003 | 27780 | Not yet classified | Terminated | Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 | The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges | accessdata.fda.gov |
| November 13, 2003 | 27717 | Not yet classified | Terminated | IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 | Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances. | accessdata.fda.gov |
| November 5, 2003 | 27667 | Not yet classified | Terminated | Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 | Aspiration errors in the conjugate component due to microbial contamination of the conjugate. | accessdata.fda.gov |
| September 19, 2003 | 27374 | Not yet classified | Terminated | IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng/mL, Calibrator E ha | Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100. | accessdata.fda.gov |
| August 22, 2003 | 27069 | Not yet classified | Terminated | AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA | There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others. | accessdata.fda.gov |
| July 22, 2003 | 26868 | Not yet classified | Terminated | IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064 | The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated. | accessdata.fda.gov |
| June 12, 2003 | 26530 | Not yet classified | Terminated | AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0) | AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5% | accessdata.fda.gov |
| June 9, 2003 | 26450 | Not yet classified | Terminated | Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information section below. | The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin. | accessdata.fda.gov |
| May 30, 2003 | 26430 | Not yet classified | Terminated | Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064 | The Free T4 Controls, may yield control values that are high and outside of the package insert ranges. | accessdata.fda.gov |
| May 13, 2003 | 26349 | Not yet classified | Terminated | Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064 | The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL | accessdata.fda.gov |
| May 13, 2003 | 26348 | Not yet classified | Terminated | T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, | The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/mL | accessdata.fda.gov |
| May 13, 2003 | 26343 | Not yet classified | Terminated | LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Made in Costa Rica, Ab | IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced. | accessdata.fda.gov |
| April 7, 2003 | 25957 | Not yet classified | Terminated | Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 | Particulate matter in the microparticle component. | accessdata.fda.gov |
| March 31, 2003 | 25904 | Not yet classified | Terminated | Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 | Lot gives lower specimen results compared to results generated with other lots. | accessdata.fda.gov |
| March 4, 2003 | 25690 | Not yet classified | Terminated | Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064 | The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens. | accessdata.fda.gov |
| March 4, 2003 | 25689 | Not yet classified | Terminated | Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, | The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values | accessdata.fda.gov |
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Updated April 22, 2025. 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.