bioMerieux, Inc.
Durham, NC, US
BIOMERIEUX, INC. appears in FDA device records in Durham, NC. FDA records list 408 510(k) clearances between and , 84 PMA records and 10 registered establishments. As of , FDA records show 638 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to bioMerieux, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Biomerieux France Chemin De L'Orenforcement report, recall
- Merck Teknika LLCregistration
- Organon Teknika Corp.510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 408FDA records hold 408 510(k) clearances for bioMerieux, Inc. between 1980 and 2026. The busiest year on record is 1985, with 45. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 5 |
| 1981 | 2 |
| 1982 | 2 |
| 1983 | 31 |
| 1984 | 8 |
| 1985 | 45 |
| 1986 | 7 |
| 1987 | 19 |
| 1988 | 15 |
| 1989 | 3 |
| 1990 | 5 |
| 1991 | 6 |
| 1992 | 5 |
| 1993 | 2 |
| 1994 | 10 |
| 1995 | 13 |
| 1996 | 1 |
| 1997 | 7 |
| 1998 | 4 |
| 1999 | 11 |
| 2000 | 6 |
| 2001 | 1 |
| 2002 | 11 |
| 2003 | 12 |
| 2004 | 7 |
| 2005 | 12 |
| 2006 | 3 |
| 2007 | 9 |
| 2008 | 9 |
| 2009 | 9 |
| 2010 | 6 |
| 2011 | 11 |
| 2012 | 12 |
| 2013 | 10 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 7 |
| 2017 | 16 |
| 2018 | 5 |
| 2019 | 14 |
| 2020 | 5 |
| 2021 | 6 |
| 2022 | 9 |
| 2023 | 9 |
| 2024 | 4 |
| 2025 | 4 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | SAN | Substantially Equivalent | |
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | JWY | Substantially Equivalent | |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | LON | Substantially Equivalent | |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | LON | Substantially Equivalent | |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | LON | Substantially Equivalent | |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | JWY | Substantially Equivalent | |
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | JWY | Substantially Equivalent | |
| K234012 | VITEK COMPACT PRO | LON | Substantially Equivalent | |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | NGZ | Substantially Equivalent | |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | NGZ | Substantially Equivalent | |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | QAT | Substantially Equivalent | |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | LON | Substantially Equivalent | |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | LON | Substantially Equivalent | |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | JWY | Substantially Equivalent | |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | LON | Substantially Equivalent | |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | LON | Substantially Equivalent | |
| K222430 | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin | LON | Substantially Equivalent | |
| K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin | LON | Substantially Equivalent | |
| K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | LON | Substantially Equivalent | |
| K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | LON | Substantially Equivalent | |
| K220803 | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin | LON | Substantially Equivalent | |
| K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen | LON | Substantially Equivalent | |
| K212243 | VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) | LON | Substantially Equivalent | |
| K213899 | VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin | LON | Substantially Equivalent | |
| K210793 | VIDAS NEPHROCHECK | PIG | Substantially Equivalent | |
| K213931 | VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) | LON | Substantially Equivalent | |
| K214023 | VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) | LON | Substantially Equivalent | |
| K212461 | VITEK MS PRIME | QBN | Substantially Equivalent | |
| K213241 | VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole | LON | Substantially Equivalent | |
| K212849 | VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) | LON | Substantially Equivalent | |
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | JWY | Substantially Equivalent | |
| K210287 | VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) | LON | Substantially Equivalent | |
| K202396 | VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) | LON | Substantially Equivalent | |
| K211630 | VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) | LON | Substantially Equivalent | |
| K201675 | VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) | LON | Substantially Equivalent | |
| K211136 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) | LON | Substantially Equivalent | |
| K193299 | VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) | LON | Substantially Equivalent | |
| K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) | JWY | Substantially Equivalent | |
| K200590 | VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) | LON | Substantially Equivalent | |
| K193572 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) | LON | Substantially Equivalent | |
| K193567 | VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL) | LON | Substantially Equivalent | |
| K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | JWY | Substantially Equivalent | |
| K192110 | Vitek Densichek | LON | Substantially Equivalent | |
| K192050 | ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) | JWY | Substantially Equivalent | |
| K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | JWY | Substantially Equivalent | |
| K191766 | VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) | LON | Substantially Equivalent | |
| K190616 | VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) | LON | Substantially Equivalent | |
| K190405 | BACT/ALERT MP Reagent System | MDB | Substantially Equivalent | |
| K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | JWY | Substantially Equivalent | |
| K183524 | VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) | LON | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013394941 | 3013394941 | BIOMERIEUX SA | 4 bis, rue des Coutures, Combourg Ille-et-Vilaine 35270 FR | 2026 | |
| 8020790 | 1000611339 | BIOMERIEUX SA | CHEMIN DE L ORME, MARCY L ETOILE Rhone 69280 FR | 2026 | and 21 more, listed in full below |
| 9615754 | 3008237827 | BIOMERIEUX SA | 3 ROUTE DE PORT MICHAUD, LA BALME LES GROTTES Isere 38390 FR | 2026 | and 12 more, listed in full below |
| 1450405 | 1450405 | BIOMERIEUX, INC. | 1105 N Main St, LOMBARD, IL 60148 US | 2026 | |
| 1950204 | 1950204 | BIOMERIEUX, INC. | 595 ANGLUM RD., HAZELWOOD, MO 63042 US | 2026 | and 9 more, listed in full below |
| 3002769706 | 3002769706 | BIOMERIEUX, INC. | 100 RODOLPHE ST, DURHAM, NC 27712 US | 2026 | |
| 3025775667 | 3025775667 | BIOMERIEUX, INC. | 1201 S 4800 W, Salt Lake City, UT 84104 US | 2026 | |
| 9615778 | 1000351505 | BioMerieux SA | PARC TECHNOLOGIQUE DELTA SUD, VERNIOLLE Ariege 09340 FR | 2026 | |
| 1039284 | 1039284 | Merck Teknika LLC | 100 Rodolphe Street, Durham, NC 27712 US | 2026 | |
| 3031977134 | 3031977134 | bioMerieux, Inc. | 3015 Carrington Mill Blvd, Morrisville, NC 27560 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GFOActivated Partial Thromboplastin
- JHJAgglutination Method, Human Chorionic Gonadotropin
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GTYAntigens, All Groups, Streptococcus Spp.
- JQPCalculator/Data Processing Module, For Clinical Use
- GKGCentrifuge, Hematocrit
- JJHClinical Sample Concentrator
- JHYColorimetric Method, Cpk Or Isoenzymes
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- JSCCulture Media, General Nutrient Broth
- JSECulture Media, Multiple Biochemical Test
- JSHCulture Media, Non-Selective And Differential
- JSGCulture Media, Non-Selective And Non-Differential
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- JSDCulture Media, Selective Broth
- JSFCulture Media, Single Biochemical Test
- JCADevice, Bleeding Time
- FJIDialyzer, Capillary, Hollow Fiber
- JJTEnzyme Controls (Assayed And Unassayed)
- GHHFibrin Split Products
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- DATFibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
- JFTFluorometric, Cortisol
- DEWIgg, Antigen, Antiserum, Control
- JNLImmunochemical, Thyroglobulin Autoantibody
- FKLInsert, Pump, Blood
- GKPInstrument, Coagulation, Automated
- JSPKit, Anaerobic Identification
- JSSKit, Identification, Enterobacteriaceae
- CAKMicrofilter, Blood Transfusion
- FLAMonitor, Temperature, Dialysis
- JJMOsmometer For Clinical Use
- GGNPlasma, Coagulation Control
- DDFProthrombin, Antigen, Antiserum, Control
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- GITReagent & Control, Partial Thromboplastin Time
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- JQWStation, Pipetting And Diluting, For Clinical Use
- FIPSubsystem, Water Purification
- FKQSystem, Dialysate Delivery, Central Multiple Patient
- FKPSystem, Dialysate Delivery, Single Patient
- FKTSystem, Dialysate Delivery, Sorbent Regenerated
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- FKXSystem, Peritoneal, Automatic Delivery
- DHXSystem, Test, Carcinoembryonic Antigen
- DHASystem, Test, Human Chorionic Gonadotropin
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJSTest, Time, Prothrombin
- GIMTubes, Vacuum Sample, With Anticoagulant
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
Showing 25 of 638| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2715-2026 | VITEK 2 AST-N447 TEST KIT Product reference 424620 | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. | Class II | Open, Classified | |
| Z-1236-2026 | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.*** AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491 | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results. | Class II | Open, Classified | |
| Z-2671-2025 | VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards | Class II | Open, Classified | |
| Z-1464-2024 | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721 | Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2. | Class I | Open, Classified | |
| Z-1201-2023 | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS). | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician. | Class II | Open, Classified | |
| Z-0876-2023 | PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0875-2023 | PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0874-2023 | PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0873-2023 | PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0872-2023 | PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0871-2023 | PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0870-2023 | PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0869-2023 | DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0868-2023 | VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0867-2023 | VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0866-2023 | VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0865-2023 | VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0864-2023 | VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0863-2023 | ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0862-2023 | ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0861-2023 | VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0860-2023 | ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0859-2023 | ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0858-2023 | PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified | |
| Z-0857-2023 | VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain