BioMerieux SA
BioMerieux SA appears in FDA public data with 476 recalls — including 18 Class I (most serious) —, 271 510(k) clearances, 17 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2715-2026, Class II) was initiated on June 4, 2026. Its most recent 510(k) clearance was granted on July 8, 2026.
Summary
- Total Recalls
- 476 (18 Class I)
- 510(k) Clearances
- 271
- Inspections
- 17
- Compliance Actions
- 2
Known Names
biomerieux, biomerieux vitek, biomerieux italia, biomerieux colombia, biomerieux sa
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2715-2026 | Class II | VITEK 2 AST-N447 TEST KIT Product reference 424620 | June 4, 2026 |
| Z-1236-2026 | Class II | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam | January 5, 2026 |
| Z-2671-2025 | Class II | VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is a | June 26, 2025 |
| Z-1464-2024 | Class I | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST | March 14, 2024 |
| Z-1201-2023 | Class II | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology lab | February 6, 2023 |
| Z-0837-2023 | Class II | VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437 | November 9, 2022 |
| Z-0800-2023 | Class II | VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706 | November 9, 2022 |
| Z-0813-2023 | Class II | PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849 | November 9, 2022 |
| Z-0786-2023 | Class II | API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 | November 9, 2022 |
| Z-0835-2023 | Class II | VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 | November 9, 2022 |
| Z-0784-2023 | Class II | API 20 E 25 STRIPS, CATALOG 20100 | November 9, 2022 |
| Z-0810-2023 | Class II | API JAMES 2AMP, CATALOG 70542 | November 9, 2022 |
| Z-0817-2023 | Class II | ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 | November 9, 2022 |
| Z-0821-2023 | Class II | ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302 | November 9, 2022 |
| Z-0802-2023 | Class II | PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841 | November 9, 2022 |
| Z-0843-2023 | Class II | VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670 | November 9, 2022 |
| Z-0825-2023 | Class II | ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373 | November 9, 2022 |
| Z-0840-2023 | Class II | GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 | November 9, 2022 |
| Z-0807-2023 | Class II | BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017 | November 9, 2022 |
| Z-0848-2023 | Class II | VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915 | November 9, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | July 8, 2026 |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | April 15, 2026 |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | March 26, 2026 |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | August 21, 2025 |
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | April 30, 2025 |
| K234012 | VITEK COMPACT PRO | March 14, 2025 |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | June 12, 2024 |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | June 7, 2024 |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | May 1, 2024 |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | March 11, 2024 |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 | October 23, 2023 |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µ | July 5, 2023 |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | June 26, 2023 |
| K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µ | February 16, 2023 |
| K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | February 9, 2023 |
| K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | February 3, 2023 |
| K220803 | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 | January 27, 2023 |
| K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen | October 13, 2022 |
| K212243 | VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) | August 8, 2022 |
| K213899 | VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 | July 12, 2022 |