HIGH

bioMerieux Recalls VITEK 2 AST Test Kits Over False Resistance Risk

bioMerieux recalled 235,269 VITEK 2 Gram-negative AST Test Kits on June 26, 2025. The recall follows potential false resistant results for Colistin with specific bacteria. This may affect patient treatment decisions in multiple countries.

Quick Facts at a Glance

Recall Date
June 26, 2025
Hazard Level
HIGH
Brand
bioMerieux
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact bioMerieux, Inc. or your healthcare provider for instructions. Notification method: Letter

Product Details

The recalled product includes VITEK 2 Gram-negative AST Test Kits containing Colistin formulation cs02n. The affected models include AST-N412, AST-N427, AST-N438, AST-N439, and others, sold internationally.

The Hazard

These test kits may produce false resistant results for Colistin when testing multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii. This could lead to inappropriate treatment of serious infections.

Reported Incidents

No specific injuries or deaths have been reported linked to this recall. The product is considered high-risk due to the potential for incorrect treatment outcomes.

What to Do

Healthcare providers and patients should stop using the affected test kits immediately. Contact bioMerieux, Inc. or your healthcare provider for specific instructions on the recall.

Contact Information

For more details, call bioMerieux, Inc. at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2671-2025.

Key Facts

  • Recall date: June 26, 2025
  • Quantity recalled: 235,269 cards
  • International distribution in multiple countries
  • Potential for false resistance results
  • Class II recall status
View Original Recall on FDA - Medical Devices

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeAST Test Kits
Sold At
Multiple Retailers

Product Details

Model 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
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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