bioMerieux, Inc.

• LON — Microbiology114 devices
• JSJ — Microbiology18 devices
• JSG — Microbiology13 devices
• JSH — Microbiology12 devices
• MDB — Microbiology12 devices
• JSI — Microbiology11 devices
• NGZ — Microbiology10 devices
• JSF — Microbiology7 devices
• DAP — Hematology4 devices
• JSO — Microbiology4 devices

• Z-3231-2026 — VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811Class II·Ongoing·2026-07-24
• Z-2715-2026 — VITEK 2 AST-N447 TEST KIT Product reference 424620Class II·Ongoing·2026-06-04
• Z-1236-2026 — 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 REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309Class II·Ongoing·2026-01-05
• Z-2671-2025 — VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export onlyClass II·Ongoing·2025-06-26
• Z-1464-2024 — 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) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721Class I·Ongoing·2024-03-14
• Z-1201-2023 — 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).Class II·Ongoing·2023-02-06
• Z-0851-2023 — ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553Class II·Ongoing·2022-11-09
• Z-0843-2023 — VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670Class II·Ongoing·2022-11-09
• Z-0825-2023 — ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373Class II·Ongoing·2022-11-09
• Z-0794-2023 — PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588Class II·Ongoing·2022-11-09

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K260283 — VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)Product code LON·2026-10-01
• K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemProduct code SAN·2026-07-08
• K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceProduct code LON·2026-04-15
• K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)Product code LON·2025-08-21
• K234012 — VITEK COMPACT PROProduct code LON·2025-03-14
• K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)Product code NGZ·2024-06-12
• K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)Product code NGZ·2024-06-07
• K240279 — VIDAS TBI (GFAP, UCH-L1)Product code QAT·2024-05-01
• K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)Product code LON·2024-03-11
• K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus PenicillinProduct code LON·2023-10-23
• 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 DaptomycinProduct code LON·2023-07-05
• K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)Product code LON·2023-06-26
• K223478 — VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL)Product code LON·2023-02-16
• K222073 — VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)Product code LON·2023-02-09
• K223481 — VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)Product code LON·2023-02-03
• 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 MoxifloxacinProduct code LON·2023-01-27
• K220805 — VITEK 2 AST-Gram Positive Cefoxitin ScreenProduct code LON·2022-10-13
• K212243 — VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)Product code LON·2022-08-08
• 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 CaspofunginProduct code LON·2022-07-12
• K213931 — VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)Product code LON·2022-06-03
• K214023 — VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)Product code LON·2022-04-14
• K212461 — VITEK MS PRIMEProduct code QBN·2022-03-15
• 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 FluconazoleProduct code LON·2022-02-25
• K210287 — VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)Product code LON·2021-10-28
• K202396 — VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)Product code LON·2021-09-14
• K211630 — VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)Product code LON·2021-08-30
• K201675 — VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)Product code LON·2021-07-09
• K211136 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)Product code LON·2021-06-14
• K193299 — VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)Product code LON·2020-09-28
• K200590 — VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)Product code LON·2020-04-28
• K193572 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)Product code LON·2020-03-13
• K193567 — VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL)Product code LON·2020-02-14
• K192110 — Vitek DensichekProduct code LON·2019-10-31
• K191766 — VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)Product code LON·2019-08-05
• K190616 — VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)Product code LON·2019-06-06
• K190405 — BACT/ALERT MP Reagent SystemProduct code MDB·2019-05-15
• K183524 — VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)Product code LON·2019-03-12
• K183551 — VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)Product code LON·2019-03-07
• K183360 — VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL)Product code LON·2019-02-26
• K183415 — VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)Product code LON·2019-02-20
• K183166 — BacT/ALERT FA Plus; BacT/ALERT PF PlusProduct code MDB·2019-02-11
• K181412 — VITEK MSProduct code QBN·2018-12-21
• K181766 — VITEK 2 AST-Gram Positive Inducible Clindamycin ResistanceProduct code LON·2018-12-10
• K181368 — VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)Product code NGZ·2018-06-20
• K172944 — VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mLProduct code LON·2017-12-19
• K172731 — VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)Product code LON·2017-12-08
• K172150 — Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)Product code JWY·2017-09-15
• K162950 — VITEK MSProduct code PEX·2017-07-22
• K162737 — VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)Product code LON·2017-06-21
• K170670 — Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)Product code JWY·2017-05-31
• K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUOProduct code MDB·2017-03-28
• K163563 — VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL)Product code LON·2017-03-13
• K162827 — VIDAS B.R.A.H.M.S. PCT (PCT)Product code PRI·2017-02-23
• K161437 — VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)Product code LON·2017-02-16
• K161510 — VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)Product code LON·2017-02-13
• K163083 — VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)Product code LON·2017-02-01
• K163042 — chromID Strepto B agarProduct code PQZ·2017-01-27
• K163006 — VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)Product code LON·2017-01-24
• K161217 — VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)Product code LON·2017-01-12
• K162076 — chromID MRSAProduct code JSO·2016-10-25
• K161227 — VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)Product code LON·2016-07-20
• K160911 — VIDAS B.R.A.H.M.S. PCT (PCT)Product code PMT·2016-06-28
• K152075 — VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)Product code LON·2016-04-15
• K151923 — VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)Product code NGZ·2016-03-25
• K151688 — chromID MRSAProduct code JSO·2016-03-11
• K151817 — VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLProduct code NGZ·2016-02-18
• K133952 — VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINEProduct code NGZ·2014-08-19
• K133817 — VITEK 2 AST - YEAST FLUCONAZOLEProduct code NGZ·2014-08-05
• K141149 — VITEK 2 AST GP CEFTAROLINEProduct code LON·2014-06-20
• K132507 — VITEK 2 AST ST MEROPENEMProduct code LON·2013-11-15
• K131779 — VITEK 2 AST-ST TIGECYCLINEProduct code LON·2013-10-10
• K132573 — VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACINProduct code LON·2013-09-13
• DEN130013 — VITEK MSProduct code PEX·2013-08-21
• K121446 — BACT/ALERT PF PLUS CULTURE BOTTLEProduct code MDB·2013-01-25
• K121455 — BACT/ALERT FN PLUS CULTURE BOTTLEProduct code MDB·2013-01-25
• K121461 — BACT/ALERT FA PLUS CULTURE BOTTLEProduct code MDB·2013-01-22
• K121546 — VITEK 2 GRAM NEGATIVE DOXYCYCLINEProduct code LON·2012-11-20
• K121100 — VITEK 2 AST STREPTOCOCUS VANCOMYCINProduct code LON·2012-11-19
• K122547 — GRAM POSTITVE CLINDAMYCINProduct code LON·2012-10-15
• K121002 — ETEST CEFTAROLINEProduct code JWY·2012-10-12
• K122359 — VITEK 2 STRPTOCOCCUS CEFTRIAXONEProduct code LON·2012-08-28
• K121863 — VITEK 2 AST-ST CEFOTAXIMEProduct code LON·2012-08-16
• K113783 — VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAEProduct code LON·2012-08-07
• K112818 — VIDAS D-DIMER EXCLUSION II (DEX2)Product code DAP·2012-07-31
• K113200 — VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAMProduct code LON·2012-06-29
• K111893 — VITEK(R) 2 STREPTOCOCCUS TETRACYCLINEProduct code LON·2012-02-28
• K111976 — VITEK 2 STREPTOCOCCUS ERYTHROMYCINProduct code LON·2012-02-17
• K113305 — VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLEProduct code LON·2012-02-10
• K110106 — VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLEProduct code LON·2011-11-30
• K112000 — VITEK 2 STREPTOCOCCUS PENICILLINProduct code LON·2011-10-26
• K111909 — VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCEProduct code LON·2011-10-18
• K103752 — VITEK 2 SYSTEMS (PC) 5.02 SOFTWAREProduct code LON·2011-10-14
• K112228 — VITEK 2 STREPTOCOCCUS LEVOFLOXACINProduct code LON·2011-10-03
• K112129 — VITEK(R) 2 STREPTOCOCCUS CLINDAMYCINProduct code LON·2011-09-27
• K112075 — VITEK 2 STRPTOCOCCUS AMPICILLINProduct code LON·2011-09-15
• K111599 — VITEK 2 AST-ST LINEZOLIDProduct code LON·2011-08-12
• K102740 — NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6Product code NQX·2011-05-20
• K101946 — VIDAS TOXO IGG AVIDITYProduct code LGD·2011-05-18
• K093076 — VITEK 2 GRAM POSITIVE DOXCYCLINEProduct code LON·2010-10-21
• K101566 — VITEK 2 YEAST CASPOFUNGINProduct code NGZ·2010-09-28