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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
bioMerieux, Inc.
Reason for Recall:
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2671-2025

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