Quick Facts at a Glance
- Recall Date
- January 5, 2026
- Hazard Level
- HIGH
- Brand
- Biomerieux
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- 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
- Antibiotic Susceptibility Testing Cards
- Model numbers
- All lot codes of the identified Gram-negative AST test kits.
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 5, 2026
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
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
The VITEK 2 Gram-negative susceptibility cards are used in laboratories to determine the sensitivity of bacteria to various antibiotics. Laboratories and healthcare providers rely on accurate results for effective treatment of infections.
Why This Is Dangerous
The identified hazard involves potential inaccuracies in test results, which may lead to inappropriate antibiotic usage and ineffective treatment plans. This can result in serious health risks for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers and healthcare providers must be vigilant about the use of these cards, as incorrect test results can compromise patient safety and treatment efficacy.
Practical Guidance
How to identify if yours is affected
- Check the product packaging for lot codes to determine if your cards are affected.
- Contact your healthcare provider for additional verification if needed.
- Review any notification letters from Biomerieux regarding the recall.
Where to find product info
Lot codes can typically be found on the packaging of the susceptibility cards or in accompanying documentation.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document your communication attempts and keep records of correspondence.
- Escalate the issue by contacting consumer protection agencies if the company does not respond.
How to prevent similar issues
- When purchasing medical devices, look for FDA approval and quality assurance certifications.
- Regularly check for product recalls and safety notices from manufacturers and government agencies.
Documentation advice
Keep records of your purchase, any communication with the manufacturer, and photos of the product as evidence.
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Product Details
The recall includes all lot codes of the VITEK 2 Gram-negative susceptibility cards. The affected products were distributed worldwide, including the United States.
Key Facts
- Recall date: January 5, 2026
- Affected species: Enterobacterales/Enterobacteriaceae and Pseudomonas aeruginosa
- Class II recall due to high hazard level
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Safety Guide
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