FDA alerts to Class I recall of VITEK 2 AST Kit by BioMérieux Inc. due to high Ceftriazone concentrations

The FDA is warning consumers that the VITEK 2 AST kit, developed for antimicrobial sensitivity testing, has been recalled by BioMérieux Inc. because it was found to contain above-approved concentrations of Ceftriaxone.

Initiated by the firm on March 14, 2024, an FDA update posted April 30, 2024, has identified the recall as Class I, the most serious type, because use of the devices may lead to major injuries or death.

The recall covers 49,276 kits–a total of 985,520 tests–that were distributed across the U.S. between December 12, 2023 and March 4, 2024. A complete list of the affected products, along with their lot numbers, expiry dates, and UDIs, can be referenced in the FDA announcement.

One kit includes a Gram-negative Susceptibility Card containing a variety of antibiotics and which is dried with a special bacteria conducive to bacteria growth. Used to test how certain types of bacteria react to antibiotics, the VITEK 2 device monitors bacteria growth in each well on the card, for a pre-determined time interval. The machine then yields results that indicate the minimal inhibitory concentration (MIC) for the majority of bacteria and drug combinations. It also shows the relationship of certain bacteria to the antibiotics: susceptible (S), intermediate (I), or resistant (R).

Officials moved to recall the VITEK 2 AST cards that make up the Antimicrobial Sensitivity Testing kit after it was discovered that 2 wells contained a higher concentration of Ceftriaxone antibiotic than should be there.

Healthcare professionals who administer the bioMérieux VITEK 2 AST cards to determine “the susceptibility of bacteria to antimicrobial agents” are advised to stay up to date on the recall, and are urged to use an alternate testing method in the event that the MIC (minimal inhibitory concentration) results are shown to be in the 0.5, 1, 2 range.

While the company has not received any reports of injuries or other related adverse outcomes, an Urgent Field Safety Notice sent to all affected bioMérieux customers on March 15, 2024 outlined the following requests:

  • The kits may continue to be used, but alternative methods to determine MIC should be considered if the kit shows the MIC to be 0.5, 1, or 2.
  • Copies of this product recall announcement should be made and distributed to all personnel who use or could potentially use the kits.
  • The Urgent Field Safety Notice should be stored and/or displayed along with the bioMérieux VITEK 2 documentation.
  • The Acknowledgement Form attached to the notice should be completed and returned to Usfieldactions@biomerieux.com to acknowledge receipt of the communication.

U.S. customers may direct further recall-related questions to bioMérieux Clincal Customer Service by calling 1-800-682-2666. Those with non-emergency questions are asked to reach out to the company’s Technical Support Center via email at CustomerService-IDAST@biomerieux.com. During regular business hours, customers can generally expect a response to email inquiries within 24 to 48 hours.

As the FDA continues to oversee the recall, the agency asks that healthcare professionals and consumers report any adverse experiences to its MedWatch program.


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