Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-1137-2019 · Posted None

Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeLON
Date Initiated2019-03-15
Date Terminated2021-08-17
Product Quantity10784 cartons

Reason for Recall

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.

Firm Action

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."

Root Cause

Software change control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑