Z-1137-2019Class II

Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent...

Name: Z-1137-2019 Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent...
Creator: bioMerieux, Inc.
Published: 2019-03-15
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2019-03-15 / Terminated / root cause: software

FDA source

bioMerieux, Inc. began a recall of Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and... on 2019-03-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1137-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-15
Posted: 2019-04-12
Terminated: 2021-08-17
Recalling firm: bioMerieux, Inc.
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.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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.
Root cause tag: software
FDA root cause: Software change control
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."
Quantity in commerce: 10784 cartons
Distribution: Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1137-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1137-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-12

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)