HIGH

bioMerieux VITEK 2 AST Cards Recalled for False Colistin Results (235,269 Cards) 2025

bioMerieux recalled 235,269 VITEK 2 Gram-negative AST test cards containing Colistin cs02n, distributed internationally. The cards may produce false resistant results for Colistin when testing certain multi-drug-resistant bacteria. Healthcare providers should stop using the affected cards immediately and follow the recall instructions from bioMerieux.

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

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About This Product

VITEK 2 AST Test Kits are an automated system comprising instruments, software and reagent cards used for identifying bacteria and testing antimicrobial susceptibility.

Why This Is Dangerous

The Colistin cs02n formulation in certain cards can produce false resistant results. This misleads treatment decisions for infections caused by Gram-negative bacteria.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and labs may need to halt testing with affected cards and consult alternate methods, potentially affecting antibiotic therapy decisions and patient outcomes.

Practical Guidance

How to identify if yours is affected

  1. 1. List model numbers on your VITEK 2 SUV cards.
  2. 2. Cross-check with the recall list of affected AST cards (AST-N412, AST-N427, AST-N438, AST-N439, AST-N440, AST-N443, AST-N444, AST-N447, AST-N448, AST-N462, AST-N463, AST-N465, AST-N475, AST-N476, AST-N477, AST-XN21, AST-XN22, AST-XN24, AST-XN25, AST-XN28, AST-XN29, AST-XN35, AST-XN37).
  3. 3. Inspect batch numbers printed on cards where available (examples in the recall notice).

Where to find product info

FDA recall page Z-2671-2025 and bioMerieux recall communications.

What timeline to expect

Refunds or replacements typically follow recall processing timelines provided by the manufacturer; labs should plan for updates over weeks.

If the manufacturer is unresponsive

  • Document all outreach attempts to bioMerieux.
  • Escalate to hospital compliance or regulatory authorities if there is no timely response.

How to prevent similar issues

  • Verify supplier recall status before use.
  • Maintain an updated inventory and segregation plan for recalled lots.
  • When purchasing, confirm the supplier has current recall documentation.
  • Consider parallel confirmation using alternative AST methods in high-risk settings.

Documentation advice

Keep copies of the recall notice, model numbers, batch numbers, testing dates, and all correspondence with bioMerieux and regulators.

Product Details

Quantity: 235,269 cards. Model numbers include AST-N412, AST-N427, AST-N438, AST-N439, AST-N440, AST-N443, AST-N444, AST-N447, AST-N448, AST-N462, AST-N463, AST-N465, AST-N475, AST-N476, AST-N477, AST-XN21, AST-XN22, AST-XN24, AST-XN25, AST-XN28, AST-XN29, AST-XN35, AST-XN37. Cards distributed internationally in 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,Seria

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 235,269 cards recalled
  • International distribution across multiple countries
  • Colistin cs02n false-resistance risk in Gram-negative testing
  • Immediate action required: stop use and follow recall instructions
  • Refunds/replacements to be provided per recall guidelines

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
9/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
AST-N412
AST-N427
AST-N438
AST-N439
AST-N440
+18 more
Report Date
October 8, 2025
Recall Status
ACTIVE

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