Biomerieux recalled 2,668,954 VITEK 2 Gram-negative susceptibility cards on January 5, 2026. The recall addresses potential false resistant results for certain antibiotic tests. Healthcare providers and patients must stop using the product immediately.
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.
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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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.
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.
This recall is not part of a broader industry pattern.
Consumers and healthcare providers must be vigilant about the use of these cards, as incorrect test results can compromise patient safety and treatment efficacy.
Lot codes can typically be found on the packaging of the susceptibility cards or in accompanying documentation.
Expect a refund or replacement process to take approximately 4-6 weeks after returning the product.
Keep records of your purchase, any communication with the manufacturer, and photos of the product as evidence.
The recall includes all lot codes of the VITEK 2 Gram-negative susceptibility cards. The affected products were distributed worldwide, including the United States.
Not sure what to do next? Our guide walks you through the process step by step.
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