BioMerieux, Inc. recalls VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n.…

Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards

On 06/27/2025, the firm sent an "URGENT FIELD SAFETY NOTICE" letter to customer informing them that VITEK 2 users, who are using VITEK 2 GN-AST cards with Colistin formulation, cs02n, have reported obtaining false resistant Colistin results with Acinetobacter baumannii complex and Pseudomonas aeruginosa isolates. Customers are required to: bioMrieux recommends you confirm any resistant colistin (cs02n) results for multidrug resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex isolates via an alternate method for all existing and future AST cards with cs02n. If appropriate for your laboratory, create a custom bioART rule to show when resistant colistin (cs02n) results are obtained for Pseudomonas aeruginosa and Acinetobacter baumannii complex isolates (refer to the VITEK 2 Software User Manual for instructions). Based on individual facility policy, you may wish to perform retrospective review of resistant results. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred the product. Complete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMrieux even if you determine that this product correction notice does not impact your facility. For questions or further assistance, contact the local bioMerieux Customer Service Representative.

• FDA enforcement recordOfficial FDA database entry for Z-2671-2025
• FDA device classification · LONOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.1645The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find bioMerieux, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.