—#171710

Product

Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Ref: 413723 (AST-N254), 418674 (AST-N330) and 422024 (AST-N371 Card) with 8.01/9.01 SW Unique Device Identifier: 03573026404550 (AST-N254) / 03573026474836 (AST-N330) / 03573026604363 (AST-N371)

Why it was recalled

Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.

Root cause (FDA determination)

Software change control

Action the firm took

On 03/15/2019, the firm, BioMerieux sent notifications to all their consignees with the following instructions: "Please take the following actions at this time: Confirm this letter has been distributed to, and reviewed by, all appropriate personnel within your organization. Apply the VITEK 2 Systems bioART rule criteria as previously mentioned (i.e., using the criteria listed below for ESBL / E. coli isolates). Refer to Appendix A for detailed instructions. o If the card is AST-NXXX (where XXX indicates the card type designation, 254 / 330 / 371) o The organism is Escherichia coli o And the phenotype is ESBL o And the drug cefuroxime is <=8 o And the drug ceftazidime is <=0.5 o Then stop for consultation and add a comment: There is no evidence that the isolate is an ESBL producer. The category results for cephalosporins should be interpreted as tested, before the AES expertise. Please store this letter with your bioMrieux instrument documentation. Complete the Acknowledgement Form and return it to your local bioMrieux representative. bioMrieux, Inc. is committed to providing our customers with the highest quality products, and we apologize for any inconvenience this may have caused in your laboratory. If you have any questions or concerns, please contact your local bioMrieux representative."

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.

Timeline

Recall initiated: 2019-03-15
Terminated: 2021-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171710. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.