Recall Notice for BioMérieux VITEK 2 AST Kit

Class I Recall Notice  

BioMérieux Inc. has issued a crucial recall notice for its VITEK 2 AST kit, a vital tool in determining bacterial susceptibility to antibiotics. The Food and Drug Administration (FDA) classifies this recall as Class I, indicating a severe risk of serious injuries or even fatalities associated with its use. 

Recalled Product Details 

• Product Name: VITEK 2 AST kit 
• Product Codes: LON 
• Model Numbers: Refer to the table in the FDA recall notice 
• Distribution Dates: December 12, 2023, to March 4, 2024 
• Units Recalled in the U.S.: 49,276 kits (985,520 tests) 
• Initiation Date: March 14, 2024 

Device Use and Reason for Recall 

The VITEK 2 AST kit, utilized for testing bacterial susceptibility to antibiotics, specifically came under scrutiny due to an anomaly in Ceftriaxone concentrations within two wells of the kit. This deviation poses serious health risks, including treatment failure, prolonged hospital stays, and even mortality. 

Affected Parties and Action Required 

Healthcare professionals employing the BioMérieux VITEK 2 AST cards for antimicrobial susceptibility testing must take immediate action. BioMérieux urges affected customers to continue using the kits but consider alternative methods if the minimal inhibitory concentration (MIC) falls within certain ranges. 

Steps to Take 

• Refer to the Urgent Field Safety Notice issued by BioMérieux on March 15, 2024. 
• Disseminate this information to relevant personnel and retain a copy for records. 
• Store the notice letter with VITEK 2 documentation. 
• Complete the Acknowledgement Form and return it to Usfieldactions@biomerieux.com to confirm receipt. 

Contact Information 

For inquiries regarding this recall, customers in the U.S. can reach out to bioMérieux Clinical Customer Service at 1-800-682-2666. Non-urgent inquiries can be directed to the Technical Support Center via email at CustomerService-IDAST@biomerieux.com, with an anticipated response time of 24 to 48 hours during regular business hours. 

Conclusion 

It’s imperative for healthcare professionals and users of the VITEK 2 AST kit to adhere to these guidelines to mitigate potential risks and ensure patient safety. Stay informed, take action, and prioritize patient well-being in light of this recall. 

Links 

Read the FDA recall announcement here.