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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- bioMerieux
- Product type
- Antimicrobial Susceptibility Testing (AST) Cards
- Model numbers
- AST-N412, AST-N427, AST-N438, AST-N439, AST-N440, AST-N443, AST-N444, AST-N447 +15 more
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 26, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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. List model numbers on your VITEK 2 SUV cards.
- 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.
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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
- 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
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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