VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consis

FDA device recall Z-2671-2025 · posted 2025-09-29 · Open, Classified

Recall details

Recalling firm

bioMerieux, Inc.

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LON

Quantity affected

235269 cards

Distribution

International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India,

Date initiated

2025-06-26

Date posted

2025-09-29

Location

Durham, NC