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bioMerieux, Inc.

FDA Regulatory Profile

Summary

Total Recalls
475 (18 Class I)
510(k) Clearances
268
Inspections
17
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1236-2026Class IIVITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactaJanuary 5, 2026
Z-2671-2025Class IIVITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is aJune 26, 2025
Z-1464-2024Class IVITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) ASTMarch 14, 2024
Z-1201-2023Class IIMYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology labFebruary 6, 2023
Z-0840-2023Class IIGENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057November 9, 2022
Z-0790-2023Class IIVITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345November 9, 2022
Z-0784-2023Class IIAPI 20 E 25 STRIPS, CATALOG 20100November 9, 2022
Z-0815-2023Class IIVITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071November 9, 2022
Z-0876-2023Class IIPPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035November 9, 2022
Z-0793-2023Class IIPREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586November 9, 2022
Z-0837-2023Class IIVITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437November 9, 2022
Z-0859-2023Class IIETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786November 9, 2022
Z-0825-2023Class IIETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373November 9, 2022
Z-0843-2023Class IIVITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670November 9, 2022
Z-0861-2023Class IIVITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829November 9, 2022
Z-0827-2023Class IIETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401November 9, 2022
Z-0852-2023Class IIETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560November 9, 2022
Z-0829-2023Class IIETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449November 9, 2022
Z-0809-2023Class IIAPI NIT1 NIT2 REAGENTS, CATALOG 70442November 9, 2022
Z-0810-2023Class IIAPI JAMES 2AMP, CATALOG 70542November 9, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)August 21, 2025
K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)April 30, 2025
K234012VITEK COMPACT PROMarch 14, 2025
K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)June 12, 2024
K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)June 7, 2024
K240279VIDAS TBI (GFAP, UCH-L1)May 1, 2024
K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)March 11, 2024
K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 October 23, 2023
K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µJuly 5, 2023
K222378VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)June 26, 2023
K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µFebruary 16, 2023
K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)February 9, 2023
K223481VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)February 3, 2023
K220803VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 January 27, 2023
K220805VITEK 2 AST-Gram Positive Cefoxitin ScreenOctober 13, 2022
K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)August 8, 2022
K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 July 12, 2022
K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)June 3, 2022
K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)April 14, 2022
K212461VITEK MS PRIMEMarch 15, 2022