Data / Medical devices / United States / Beckman Coulter, Inc.
Beckman Coulter, Inc.: FDA-registered device maker in West Sacramento, CA, United States, 106 510(k) clearances
Beckman Coulter, Inc. is registered with the FDA (registration 2919016) in West Sacramento, CA, United States. It lists 17 device types. The FDA files 106 510(k) clearances under its listings, the newest dated August 20, 2025. 16 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2919016
- Address
- 1584 Enterprise Blvd, West Sacramento, CA, United States, 95691
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 3, 1992
- Registered through
- 2026
- Brand names listed
- B1018-340R MicroScan WA 40 Plus Reconditioned, B1018-396R MicroScan WA 96 Plus Reconditioned, C24164 MicroScan LabPro V5 System DVD Kit (JP), C24165 MicroScan LabPro Connect V5 System DVD Kit (JP), C24166 MicroScan LabPro V5 System DVD Kit (MR), C24167 MicroScan LabPro Connect V5 System DVD Kit (MR), C38721 MicroScan LabPro V5 System DVD Kit (FMR), C38722 MicroScan LabPro Connect V5 System DVD Kit (FMR) 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 106.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 20, 2025 | K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| August 15, 2025 | K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 18, 2025 | K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 5, 2023 | K221493 | MicroScan Prompt Inoculation System-D | LIE | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| May 18, 2021 | K202423 | MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) | JWY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| November 16, 2020 | K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| August 30, 2020 | K201405 | LabPro Data Management System | LON | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| June 29, 2020 | K201423 | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 18, 2020 | K193536 | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 3, 2020 | K193358 | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| November 14, 2019 | K192355 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) | JWY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 18, 2019 | K190109 | MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) | JWY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| February 12, 2019 | K183127 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 15, 2017 | K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 7, 2017 | K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 1, 2017 | K172255 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 21, 2017 | K162740 | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) | LTT | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| September 16, 2015 | K152346 | MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) | JWY | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 2, 2015 | K150039 | MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) | LTT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 8, 2013 | K131275 | MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | Siemens Helathcare Diagnostics, Inc. | accessdata.fda.gov |
| March 14, 2013 | K123933 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE | LTT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 4, 2011 | K111677 | MICROSCAN(R) MICROSTREP PLUS(R) | LRG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 20, 2011 | K111205 | MICROSCAN (R) MICROSTREP PLUS (R) PANELS | LRG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| June 22, 2011 | K111394 | MICROSCAN MICROSTEP | LTT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| September 10, 2010 | K101425 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES | LRG | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| January 26, 2010 | K091949 | MICROSCAN MICROSTREP PLUS, MODEL B1027-201 | LTT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| July 22, 2009 | K091264 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 | LTT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| February 18, 2009 | K083262 | MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) | LTT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| September 8, 2008 | K081013 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN | LRG | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| August 8, 2008 | K081182 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN | JWY | Substantially Equivalent | Siemens | accessdata.fda.gov |
| November 27, 2006 | K063299 | MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| November 9, 2006 | K063102 | MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| November 1, 2006 | K063101 | MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| November 1, 2006 | K063099 | MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 27, 2006 | K063065 | MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 26, 2006 | K063064 | MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 26, 2006 | K063053 | MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 26, 2006 | K062375 | MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 13, 2006 | K062923 | MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 13, 2006 | K062773 | MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN | LTT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 12, 2006 | K062927 | MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| October 10, 2006 | K062777 | MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN | LTT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 19, 2006 | K062596 | MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 19, 2006 | K062585 | MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 1, 2006 | K062290 | MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 24, 2006 | K062293 | MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 23, 2006 | K062276 | MICROSCAN MICROSTREP PLUS PANEL | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 23, 2006 | K062179 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 23, 2006 | K061872 | MICROSCAN MICROSTREP PLUS PANEL | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 21, 2006 | K061687 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 18, 2006 | K061536 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| June 23, 2005 | K051202 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 29, 2005 | K050043 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 18, 2005 | K050585 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 17, 2005 | K043545 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) | LRG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 10, 2004 | K032706 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML | JWY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| June 20, 2002 | K021184 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN | LTT | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| June 17, 2002 | K021181 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| June 11, 2002 | K021018 | MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| June 6, 2002 | K021188 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| June 6, 2002 | K021169 | MICROSTREP PLUS PANEL, AZITHROMYCIN | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| June 6, 2002 | K021111 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME | LTT | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| June 6, 2002 | K021110 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| June 6, 2002 | K021078 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN | LTT | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| June 3, 2002 | K020938 | MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| May 17, 2002 | K020939 | MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE | LTT | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| May 9, 2002 | K020820 | MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME | JWY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| May 8, 2002 | K020822 | MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN | JWY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| May 6, 2002 | K021037 | MICROSTREP PLUS PANEL WITH AMPICILLIN | JWY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| May 6, 2002 | K020937 | MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| May 6, 2002 | K020627 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN | LTT | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| April 30, 2002 | K020691 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| April 30, 2002 | K020686 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| April 26, 2002 | K020626 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN | LTT | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| April 26, 2002 | K020556 | MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| March 22, 2002 | K020037 | DRIED GRAM NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| March 14, 2002 | K020162 | DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN | JWY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 14, 2002 | K020160 | DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN | LTT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 22, 2001 | K010418 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 9, 2001 | K003619 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| December 2, 1999 | K993102 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| November 18, 1998 | K981199 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN | LRG | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| October 10, 1997 | K972799 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| September 8, 1997 | K972688 | MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| May 30, 1997 | K971376 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| May 2, 1997 | K970676 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Dade Intl., Inc. | accessdata.fda.gov |
| August 16, 1996 | K962150 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | Dade Intl., Inc. | accessdata.fda.gov |
| February 23, 1996 | K955910 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Dade Microscan, Inc. | accessdata.fda.gov |
| July 18, 1995 | K934458 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Baxter Diagnostics, Inc. | accessdata.fda.gov |
| March 7, 1995 | K945235 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | Baxter Diagnostics, Inc. | accessdata.fda.gov |
| February 16, 1995 | K941030 | DRIED GRAM-NEGATIVE CEFPODOXIME | LTT | Substantially Equivalent | Baxter Diagnostics, Inc. | accessdata.fda.gov |
| December 2, 1994 | K943510 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Baxter Diagnostics, Inc. | accessdata.fda.gov |
| October 19, 1994 | K934323 | DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL | JWY | Substantially Equivalent | Baxter Diagnostics, Inc. | accessdata.fda.gov |
| March 26, 1993 | K926545 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Baxter Diagnostics, Inc. | accessdata.fda.gov |
| December 11, 1992 | K922458 | DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| November 19, 1991 | K911400 | WALKAWAY TM 40 | LRG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| August 15, 1989 | K893977 | GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| September 7, 1988 | K883076 | GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 11, 1988 | K874876 | GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL | JWY | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 14, 1987 | K870074 | GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | Microscan Div. Baxter Healthcare Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 8, 2025 | 98562 | Class II | Ongoing | MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels a | Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. | accessdata.fda.gov |
| July 24, 2025 | 98555 | Class II | Ongoing | MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively | Due to the likely presence of contamination in well(s). | accessdata.fda.gov |
| June 25, 2025 | 98553 | Class II | Ongoing | MicroScan Neg MIC 3J REF C54814 | Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics | accessdata.fda.gov |
| October 3, 2022 | 90941 | Class II | Ongoing | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 | Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. | accessdata.fda.gov |
| October 17, 2014 | 69540 | Class I | Terminated | Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aero | An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems. | accessdata.fda.gov |
| August 8, 2014 | 70893 | Class II | Terminated | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria. | accessdata.fda.gov |
| June 2, 2014 | 68524 | Class II | Terminated | MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic | Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers. | accessdata.fda.gov |
| May 14, 2014 | 70874 | Class II | Terminated | MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibilit | Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28. | accessdata.fda.gov |
| April 8, 2014 | 70904 | Class II | Terminated | MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or id | Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged without desiccants. The substrates on a panel packaged without a desiccant may deteriorate over time due to exposure to additional moisture in the panel pouch. | accessdata.fda.gov |
| August 21, 2013 | 66058 | Class I | Terminated | Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibilit | Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. | accessdata.fda.gov |
| May 2, 2013 | 65188 | Class II | Terminated | Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility. | The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction. | accessdata.fda.gov |
| March 6, 2013 | 64699 | Class II | Terminated | Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels..MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (inc | Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems. | accessdata.fda.gov |
| June 16, 2011 | 61610 | Not yet classified | Terminated | MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA. | Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels. | accessdata.fda.gov |
| July 31, 2008 | 49114 | Not yet classified | Terminated | MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identif | Falsely lowered imipenem MICs may result, leading to major errors in results. | accessdata.fda.gov |
| September 27, 2006 | 36600 | Not yet classified | Terminated | Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D | Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing. | accessdata.fda.gov |
| February 7, 2005 | 31125 | Not yet classified | Terminated | MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691 | There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy. | accessdata.fda.gov |
Compare with other makers
- All makers of Susceptibility Test Cards, Antimicrobial
- All makers of Panels, Test, Susceptibility, Antimicrobial
- All makers of Manual Antimicrobial Susceptibility Test Systems
- All makers of Culture Media, Non-Selective And Non-Differential
- All makers of Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- All makers of Kit, Identification, Yeast
Updated April 8, 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.