Recall archive / FDA device enforcement
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system c... — FDA record Z-2671-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 26, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
- Classification
- Class II
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 235269 cards
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2671-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Material Number/Material Description/Batch Number: 423936 AST-N412 TEST KIT 20 CARDS 0143139204 423936 AST-N412 TEST KIT 20 CARDS 0143254504 423936 AST-N412 TEST KIT 20 CARDS 0143303504 424196 AST-N427 TEST KIT 20 CARDS 0542849204 424196 AST-N427 TEST KIT 20 CARDS 0543190104 424196 AST-N427 TEST KIT 20 CARDS 0543266504 424196 AST-N427 TEST KIT 20 CARDS 0542951404 424196 AST-N427 TEST KIT 20 CARDS 0543190104 424196 AST-N427 TEST KIT 20 CARDS 0543289404 424499 AST-N438 TEST KIT 20 CARDS 0703181504 424499 AST-N438 TEST KIT 20 CARDS 0703218104 424499 AST-N438 TEST KIT 20 CARDS 0703273104 424499 AST-N438 TEST KIT 20 CARDS 0703125104 424501 AST-N439 TEST KIT 20 CARDS 0723192104 424501 AST-N439 TEST KIT 20 CARDS 0723048404 424501 AST-N439 TEST KIT 20 CARDS 0722971504 424501 AST-N439 TEST KIT 20 CARDS 0723237504 424501 AST-N439 TEST KIT 20 CARDS 0722860204 424502 AST-N440 TEST KIT 20 CARDS 0733170404 424502 AST-N440 TEST KIT 20 CARDS 0733317504 424502 AST-N440 TEST KIT 20 CARDS 0733170404 424541 AST-N443 TEST KIT 20 CARDS 0773230404 424541 AST-N443 TEST KIT 20 CARDS 0773247404 424541 AST-N443 TEST KIT 20 CARDS 0772911104 424587 AST-N444 TEST KIT 20 CARDS 0802553214 424587 AST-N444 TEST KIT 20 CARDS 0802553204 424620 AST-N447 TEST KIT 20 CARDS 0853198104 424620 AST-N447 TEST KIT 20 CARDS 0853247204 424633 AST-N448 TEST KIT 20 CARDS 0862971204 424633 AST-N448 TEST KIT 20 CARDS 0863202504 424633 AST-N448 TEST KIT 20 CARDS 0863296504 424839 AST-N462 TEST KIT 20 CARDS No Lots 424840 AST-N463 TEST KIT 20 CARDS No Lots 424842 AST-N465 TEST KIT 20 CARDS No Lots 424891 AST-N475 TEST KIT 20 CARDS 1703184204 424891 AST-N475 TEST KIT 20 CARDS 1703225504 424934 AST-N476 TEST KIT 20 CARDS 1713192504 425019 AST-N477 TEST KIT 20 CARDS 1733184104 425019 AST-N477 TEST KIT 20 CARDS 1733205204 425019 AST-N477 TEST KIT 20 CARDS 1733205214 424197 AST-XN21 TEST KIT 20 CARDS 0493174204 424197 AST-XN21 TEST KIT 20 CARDS 0493310504 424199 AST-XN22 TEST KIT 20 CARDS 0552981204 424199 AST-XN22 TEST KIT 20 CARDS 0553156204 424351 AST-XN24 TEST KIT 20 CARDS 0653042204 424351 AST-XN24 TEST KIT 20 CARDS 0653217504 424394 AST-XN25 TEST KIT 20 CARDS 0662155104 424394 AST-XN25 TEST KIT 20 CARDS 0662553204 424586 AST-XN28 TEST KIT 20 CARDS 0793210504 424586 AST-XN28 TEST KIT 20 CARDS 0793265504 424586 AST-XN28 TEST KIT 20 CARDS 0793295504 424586 AST-XN28 TEST KIT 20 CARDS 0793210504 424604 AST-XN29 TEST KIT 20 CARDS 0822932204 424604 AST-XN29 TEST KIT 20 CARDS 0823262504 424810 AST-XN35 TEST KIT 20 CARDS 1323087204 424888 AST-XN37 TEST KIT 20 CARDS 1693079204 AST-XN25 424394 Australia AST-N412 423936 Thailand AST-XN21 424197 Turkey AST-XN22 424199 Iberia AST-N427 424196 Iberia AST-XN24 424351 Germany AST-N439 424501 Italy AST-N440 424502 Italy AST-XN28 424586 France AST-N443 424541 France, Spain & Portugal AST-N444 424587 Russia AST-N447 424620 Netherlands AST-N448 424633 Israel AST-XN35 424810 Poland AST-N462 424839 Taiwan AST-N463 424840 Taiwan AST-N465 424842 Taiwan AST-XN37 424888 Japan AST-N475 424891 Pakistan AST-N476 424934 Pakistan AST-N477 425019 India AST-N438 424499 Italy AST-XN29 424604 Japan |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkey.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 8, 2025
- Recall initiation date
- Jun 26, 2025
- Center classification date
- Sep 29, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.