Data / Medical devices / United States / Biomerieux, Inc.
Biomerieux, Inc.: FDA-registered device maker in Hazelwood, MO, United States, 129 510(k) clearances and 1 PMA approval
Biomerieux, Inc. is registered with the FDA (registration 1950204) in Hazelwood, MO, United States. It lists 19 device types. The FDA files 129 510(k) clearances and 1 PMA approval under its listings, the newest dated October 1, 2026. 41 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1950204
- Address
- 595 Anglum RD., Hazelwood, MO, United States, 63042
- Owner or operator
- BIOMERIEUX SA (8020790)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- November 4, 2003
- Registered through
- 2027
- Brand names listed
- (240),, (<= 0.12 - >= 8 mcg/ml), (CA-SFM), , 3D MB, 3D Combination, ACETONE FUCHSIN-A, ACETONE SAFRANIN-A (NA), ACT 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 129.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 1, 2026 | K260283 | VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 28, 2026 | K260619 | VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) | LON | Substantially Equivalent | Biomérieux, Inc. | accessdata.fda.gov |
| July 8, 2026 | K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | SAN | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 15, 2026 | K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 26, 2026 | K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | LON | Substantially Equivalent | BIOMERIEUX | accessdata.fda.gov |
| August 21, 2025 | K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 14, 2025 | K234012 | VITEK COMPACT PRO | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 20, 2024 | K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | SAN | Substantially Equivalent | Specific Diagnostics, LLC | accessdata.fda.gov |
| June 12, 2024 | K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 7, 2024 | K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 11, 2024 | K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 23, 2023 | K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 5, 2023 | K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 26, 2023 | K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 9, 2023 | K222430 | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin | LON | Substantially Equivalent | Biomerieux Sa, Inc. | accessdata.fda.gov |
| February 16, 2023 | K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 9, 2023 | K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 3, 2023 | K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 27, 2023 | K220803 | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 13, 2022 | K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 8, 2022 | K212243 | VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 12, 2022 | K213899 | VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 3, 2022 | K213931 | VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 14, 2022 | K214023 | VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 25, 2022 | K213241 | VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 4, 2022 | K212849 | VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) | LON | Substantially Equivalent | Biomérieux, Inc. | accessdata.fda.gov |
| October 28, 2021 | K210287 | VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 14, 2021 | K202396 | VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 30, 2021 | K211630 | VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 9, 2021 | K201675 | VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 14, 2021 | K211136 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 28, 2020 | K193299 | VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 28, 2020 | K200590 | VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 13, 2020 | K193572 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 14, 2020 | K193567 | VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 31, 2019 | K192110 | Vitek Densichek | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 5, 2019 | K191766 | VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 6, 2019 | K190616 | VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 12, 2019 | K183524 | VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 7, 2019 | K183551 | VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 26, 2019 | K183360 | VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 20, 2019 | K183415 | VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 10, 2018 | K181766 | VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 19, 2017 | K172944 | VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 8, 2017 | K172731 | VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 21, 2017 | K162737 | VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 28, 2017 | K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 13, 2017 | K163563 | VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 16, 2017 | K161437 | VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 13, 2017 | K161510 | VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 1, 2017 | K163083 | VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 24, 2017 | K163006 | VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 12, 2017 | K161217 | VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 20, 2016 | K161227 | VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 15, 2016 | K152075 | VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 25, 2016 | K151923 | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 18, 2016 | K151817 | VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 19, 2014 | K133952 | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 5, 2014 | K133817 | VITEK 2 AST - YEAST FLUCONAZOLE | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 20, 2014 | K141149 | VITEK 2 AST GP CEFTAROLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 15, 2013 | K132507 | VITEK 2 AST ST MEROPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 10, 2013 | K131779 | VITEK 2 AST-ST TIGECYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 13, 2013 | K132573 | VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 20, 2012 | K121546 | VITEK 2 GRAM NEGATIVE DOXYCYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 19, 2012 | K121100 | VITEK 2 AST STREPTOCOCUS VANCOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 15, 2012 | K122547 | GRAM POSTITVE CLINDAMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 28, 2012 | K122359 | VITEK 2 STRPTOCOCCUS CEFTRIAXONE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 16, 2012 | K121863 | VITEK 2 AST-ST CEFOTAXIME | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 7, 2012 | K113783 | VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 29, 2012 | K113200 | VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 28, 2012 | K111893 | VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 17, 2012 | K111976 | VITEK 2 STREPTOCOCCUS ERYTHROMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 10, 2012 | K113305 | VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 30, 2011 | K110106 | VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 26, 2011 | K112000 | VITEK 2 STREPTOCOCCUS PENICILLIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 18, 2011 | K111909 | VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 14, 2011 | K103752 | VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 3, 2011 | K112228 | VITEK 2 STREPTOCOCCUS LEVOFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 27, 2011 | K112129 | VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 15, 2011 | K112075 | VITEK 2 STRPTOCOCCUS AMPICILLIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 12, 2011 | K111599 | VITEK 2 AST-ST LINEZOLID | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 21, 2010 | K093076 | VITEK 2 GRAM POSITIVE DOXCYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 28, 2010 | K101566 | VITEK 2 YEAST CASPOFUNGIN | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 21, 2010 | K092454 | VITEK 2 YEAST VORICONAZOLE | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 9, 2009 | K093224 | DENSICHECK PLUS | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 11, 2009 | K083536 | DENSICHEK PLUS | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 14, 2009 | K091899 | VITEK 2 GRAM NEGATIVE MEROPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 18, 2009 | K091126 | VITEK 2 GRAM POSITIVE DAPTOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 16, 2009 | K082346 | VITEK 2 GRAM NEGATIVE DORIPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 18, 2009 | K083383 | VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 30, 2008 | K080201 | VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 28, 2008 | K080107 | VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 23, 2008 | K073406 | VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 10, 2007 | K073083 | VITEK 2 GRAM NEGATIVE PIPERACILLIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 16, 2007 | K072695 | VITEK 2 GRAM POSITIVE TIGECYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 15, 2007 | K072668 | VITEK 2 GRAM POSITIVE VANCOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 12, 2007 | K072038 | VITEK 2 GRAM NEGATIVE LEVOFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 19, 2007 | K063597 | VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 11, 2007 | K063623 | VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 21, 2006 | K063492 | VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 2, 1978 | N50510 | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD | LTW | 130 | October 17, 2001 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 24, 2026 | 99749 | Class II | Ongoing | VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 | The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side | accessdata.fda.gov |
| June 4, 2026 | 99213 | Class II | Ongoing | VITEK 2 AST-N447 TEST KIT Product reference 424620 | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. | accessdata.fda.gov |
| January 5, 2026 | 98268 | Class II | Ongoing | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFEREN | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results. | accessdata.fda.gov |
| March 14, 2024 | 94264 | Class I | Ongoing | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) A | Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2. | accessdata.fda.gov |
| February 6, 2023 | 91617 | Class II | Ongoing | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS). | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician. | accessdata.fda.gov |
| November 9, 2022 | 91148 | Class II | Ongoing | API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | accessdata.fda.gov |
| December 20, 2021 | 89329 | Class II | Terminated | API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inocul | Risk of misidentification or delayed results with the absence of identification due to thermoforming defect. | accessdata.fda.gov |
| November 9, 2021 | 89041 | Class II | Terminated | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD. | There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test. | accessdata.fda.gov |
| June 24, 2021 | 88242 | Class II | Terminated | ETEST IMIPENEM RELEBACTAM. in vitro diagnostic | Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains. | accessdata.fda.gov |
| March 16, 2021 | 87555 | Class II | Terminated | VIDAS CMV IgM 30 Tests | bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205; 30205-01). | accessdata.fda.gov |
| January 28, 2021 | 87249 | Class II | Terminated | VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system | bioMrieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK 2. If the isolate | accessdata.fda.gov |
| March 11, 2020 | 85209 | Class II | Ongoing | The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalac | There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403).. | accessdata.fda.gov |
| October 22, 2019 | 84464 | Class II | Terminated | BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation | Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software co | accessdata.fda.gov |
| January 11, 2019 | 81934 | Class II | Terminated | Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223 | This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative ESBL Test - result in a false positive urea (URE) reaction on ID cards | accessdata.fda.gov |
| January 23, 2018 | 80491 | Class II | Terminated | bioMrieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast. | Missing desiccant. | accessdata.fda.gov |
| October 11, 2017 | 78288 | Class II | Terminated | VITEK2 GP-ID, REF 21342 IVD | Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions Fo | accessdata.fda.gov |
| August 25, 2017 | 77935 | Class II | Terminated | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC 700327(TM) strain is positive. | accessdata.fda.gov |
| July 12, 2017 | 77799 | Class II | Terminated | VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast. | Customers have reported that some VITEK 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK 2 Compact 15 and Compact 30 systems following a system software update to version 8.01. | accessdata.fda.gov |
| May 16, 2017 | 77373 | Class II | Terminated | VITEK 2 Gram Negative test kits containing colistin (cs01n) | The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI). | accessdata.fda.gov |
| April 20, 2017 | 77026 | Class II | Terminated | VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton. | The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). | accessdata.fda.gov |
| February 24, 2016 | 73585 | Class II | Terminated | VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards d | Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline. | accessdata.fda.gov |
| February 24, 2016 | 73413 | Class I | Terminated | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. | accessdata.fda.gov |
| November 23, 2015 | 72760 | Class II | Terminated | Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. | FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. | accessdata.fda.gov |
| March 27, 2015 | 70868 | Class II | Terminated | Vitek 2 AST-YS06 REF, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 | accessdata.fda.gov |
| February 25, 2015 | 70645 | Class III | Terminated | Vitek 2 AST-P635 REF Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcu | The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use. | accessdata.fda.gov |
| February 10, 2014 | 67463 | Class II | Terminated | bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO. | The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result. | accessdata.fda.gov |
| June 14, 2013 | 65470 | Class II | Terminated | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consist | A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotic | accessdata.fda.gov |
| February 18, 2013 | 64394 | Class II | Terminated | VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc71 | There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. | accessdata.fda.gov |
| February 6, 2013 | 64327 | Class II | Terminated | bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. | The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements. | accessdata.fda.gov |
| October 17, 2012 | 63479 | Class II | Terminated | 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users | The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system. | accessdata.fda.gov |
| October 16, 2012 | 63467 | Class II | Terminated | bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with | The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | accessdata.fda.gov |
| August 28, 2012 | 63019 | Class II | Terminated | PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples. | The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result. | accessdata.fda.gov |
| June 2, 2011 | 58981 | Not yet classified | Terminated | VITEK 2 System, VITEK 2 60 110V (Catalog #27225) and VITEK 2 60 220V (Catalog #27226). VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobi | Cards may not load into the incubator correctly causing them to be loaded in the wrong order which could result in the results being linked to the wrong accession number and reporting results erroneously. | accessdata.fda.gov |
| April 4, 2011 | 58135 | Not yet classified | Terminated | VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. The cards are i | The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae. | accessdata.fda.gov |
| September 16, 2010 | 56760 | Not yet classified | Terminated | VITEK 2 Gram Negative Susceptibility Card, AST-GN22, REF 22 227, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France. | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae. | accessdata.fda.gov |
| July 29, 2010 | 56365 | Not yet classified | Terminated | VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMerieux, sa, France.This | Foil pouch was punctured by drug susceptibility cards during packaging, allowing moisture into pouch, resulting in inaccurate and/or incorrect drug susceptibility results. | accessdata.fda.gov |
| March 28, 2006 | 35518 | Not yet classified | Terminated | OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D | Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID's | accessdata.fda.gov |
| April 20, 2004 | 28872 | Not yet classified | Terminated | VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC. | Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. | accessdata.fda.gov |
| April 20, 2004 | 28871 | Not yet classified | Terminated | VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC. | Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. | accessdata.fda.gov |
| January 28, 2004 | 28431 | Not yet classified | Terminated | VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC. | Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. | accessdata.fda.gov |
| January 15, 2004 | 28429 | Not yet classified | Terminated | VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France. | The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly. | accessdata.fda.gov |
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Updated October 1, 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.