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bioMerieux, Inc.

FDA Regulatory Profile

Summary

Total Recalls
475 (18 Class I)
510(k) Clearances
270
Inspections
17
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1236-2026Class IIVITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam January 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-0865-2023Class IIVIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01November 9, 2022
Z-0783-2023Class IIAPI LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300November 9, 2022
Z-0840-2023Class IIGENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057November 9, 2022
Z-0795-2023Class IIVIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217November 9, 2022
Z-0855-2023Class IIGENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105November 9, 2022
Z-0847-2023Class IIPPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751November 9, 2022
Z-0876-2023Class IIPPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035November 9, 2022
Z-0849-2023Class IIETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927November 9, 2022
Z-0839-2023Class IIPPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012November 9, 2022
Z-0829-2023Class IIETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449November 9, 2022
Z-0802-2023Class IIPPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841November 9, 2022
Z-0872-2023Class IIPPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TINovember 9, 2022
Z-0856-2023Class IIVITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416November 9, 2022
Z-0835-2023Class IIVITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404November 9, 2022
Z-0824-2023Class IIETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333November 9, 2022
Z-0813-2023Class IIPPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849November 9, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceApril 15, 2026
K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)March 26, 2026
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