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Biomerieux Inc

514 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
VITEK 2 AST-N447 TEST KIT Product reference 424620 recall (Z-2715-2026)Biomerieux Inc2026-07-09
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/ recall (Z-1236-2026)Biomerieux Inc2026-02-02
VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 recall (Z-2671-2025)bioMerieux, Inc.2025-09-29
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): recall (Z-1464-2024)Biomerieux Inc2024-04-25
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbi recall (Z-1201-2023)Biomerieux Inc2023-03-02
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300 recall (Z-0783-2023)Biomerieux Inc2023-01-04
API 20 E 25 STRIPS, CATALOG 20100 recall (Z-0784-2023)Biomerieux Inc2023-01-04
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210 recall (Z-0785-2023)Biomerieux Inc2023-01-04
API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 recall (Z-0786-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341 recall (Z-0787-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342 recall (Z-0788-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343 recall (Z-0789-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345 recall (Z-0790-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346 recall (Z-0791-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226 recall (Z-0792-2023)Biomerieux Inc2023-01-04
PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586 recall (Z-0793-2023)Biomerieux Inc2023-01-04
PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588 recall (Z-0794-2023)Biomerieux Inc2023-01-04
VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217 recall (Z-0795-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219 recall (Z-0796-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226 recall (Z-0797-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700 recall (Z-0798-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702 recall (Z-0799-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706 recall (Z-0800-2023)Biomerieux Inc2023-01-04
PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631 recall (Z-0801-2023)Biomerieux Inc2023-01-04
PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841 recall (Z-0802-2023)Biomerieux Inc2023-01-04
PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851 recall (Z-0803-2023)Biomerieux Inc2023-01-04
PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871 recall (Z-0804-2023)Biomerieux Inc2023-01-04
BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011 recall (Z-0805-2023)Biomerieux Inc2023-01-04
BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012 recall (Z-0806-2023)Biomerieux Inc2023-01-04
BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017 recall (Z-0807-2023)Biomerieux Inc2023-01-04
API VP1 VP2 REAGENTS, CATALOG 70422 recall (Z-0808-2023)Biomerieux Inc2023-01-04
API NIT1 NIT2 REAGENTS, CATALOG 70442 recall (Z-0809-2023)Biomerieux Inc2023-01-04
API JAMES 2AMP, CATALOG 70542 recall (Z-0810-2023)Biomerieux Inc2023-01-04
TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000 recall (Z-0811-2023)Biomerieux Inc2023-01-04
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016 recall (Z-0812-2023)Biomerieux Inc2023-01-04
PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849 recall (Z-0813-2023)Biomerieux Inc2023-01-04
VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893 recall (Z-0814-2023)Biomerieux Inc2023-01-04
VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071 recall (Z-0815-2023)Biomerieux Inc2023-01-04
VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072 recall (Z-0816-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 recall (Z-0817-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240 recall (Z-0818-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252 recall (Z-0819-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262 recall (Z-0820-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302 recall (Z-0821-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331 recall (Z-0822-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333 recall (Z-0823-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 recall (Z-0824-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373 recall (Z-0825-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392 recall (Z-0826-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401 recall (Z-0827-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407 recall (Z-0828-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449 recall (Z-0829-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478 recall (Z-0830-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486 recall (Z-0831-2023)Biomerieux Inc2023-01-04
BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690 recall (Z-0832-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400 recall (Z-0833-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401 recall (Z-0834-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 recall (Z-0835-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436 recall (Z-0836-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437 recall (Z-0837-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438 recall (Z-0838-2023)Biomerieux Inc2023-01-04
PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012 recall (Z-0839-2023)Biomerieux Inc2023-01-04
GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 recall (Z-0840-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 recall (Z-0841-2023)Biomerieux Inc2023-01-04
PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524 recall (Z-0842-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670 recall (Z-0843-2023)Biomerieux Inc2023-01-04
PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049 recall (Z-0844-2023)Biomerieux Inc2023-01-04
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014 recall (Z-0845-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046 recall (Z-0846-2023)Biomerieux Inc2023-01-04
PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751 recall (Z-0847-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915 recall (Z-0848-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927 recall (Z-0849-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051 recall (Z-0850-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553 recall (Z-0851-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 recall (Z-0852-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 recall (Z-0853-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102 recall (Z-0854-2023)Biomerieux Inc2023-01-04
GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105 recall (Z-0855-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416 recall (Z-0856-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425 recall (Z-0857-2023)Biomerieux Inc2023-01-04
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723 recall (Z-0858-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786 recall (Z-0859-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788 recall (Z-0860-2023)Biomerieux Inc2023-01-04
VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 recall (Z-0861-2023)Biomerieux Inc2023-01-04
ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013 recall (Z-0862-2023)Biomerieux Inc2023-01-04
ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348 recall (Z-0863-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01 recall (Z-0864-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01 recall (Z-0865-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01 recall (Z-0866-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01 recall (Z-0867-2023)Biomerieux Inc2023-01-04
VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01 recall (Z-0868-2023)Biomerieux Inc2023-01-04
DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01 recall (Z-0869-2023)Biomerieux Inc2023-01-04
PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100 recall (Z-0870-2023)Biomerieux Inc2023-01-04
PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR recall (Z-0871-2023)Biomerieux Inc2023-01-04
PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI recall (Z-0872-2023)Biomerieux Inc2023-01-04
PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040 recall (Z-0873-2023)Biomerieux Inc2023-01-04
PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065 recall (Z-0874-2023)Biomerieux Inc2023-01-04
PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR recall (Z-0875-2023)Biomerieux Inc2023-01-04
PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035 recall (Z-0876-2023)Biomerieux Inc2023-01-04
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. recall (Z-0742-2022)bioMerieux, Inc.2022-03-14
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Every clearance here is in the API, with alerts when new ones post.