Home / Companies / bioMerieux, Inc.

bioMerieux, Inc.

FDA Regulatory Profile

Summary

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

Known Names

biomerieux, biomerieux vitek, biomerieux italia, biomerieux colombia, biomerieux sa

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-0859-2023Class IIETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786November 9, 2022
Z-0814-2023Class IIVITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893November 9, 2022
Z-0807-2023Class IIBIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017November 9, 2022
Z-0810-2023Class IIAPI JAMES 2AMP, CATALOG 70542November 9, 2022
Z-0846-2023Class IIETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046November 9, 2022
Z-0835-2023Class IIVITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404November 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-0821-2023Class IIETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302November 9, 2022
Z-0848-2023Class IIVITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915November 9, 2022
Z-0838-2023Class IIVITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438November 9, 2022
Z-0783-2023Class IIAPI LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300November 9, 2022
Z-0857-2023Class IIVITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425November 9, 2022
Z-0817-2023Class IIETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218November 9, 2022
Z-0794-2023Class IIPREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588November 9, 2022
Z-0854-2023Class IIVITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102November 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