Z-0847-2019Class II

VITEK 2 AST-N351 Test Kit

Name: Z-0847-2019 VITEK 2 AST-N351 Test Kit
Creator: bioMerieux, Inc.
Published: 2018-12-13
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-12-13 / Terminated / root cause: software

FDA source

bioMerieux, Inc. began a recall of VITEK 2 AST-N351 Test Kit on 2018-12-13. FDA classified it as Class II and gives the reason as "False Positive ESBL Phenotype". 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-0847-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-13
Posted: 2019-02-16
Terminated: 2021-08-16
Recalling firm: bioMerieux, Inc.
Product: VITEK 2 AST-N351 Test Kit
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: False Positive ESBL Phenotype
Root cause tag: software
FDA root cause: Software Design Change
Action: On 12/13/2018 bioMerieux submitted a communication to their distributor in the UK stating the following: Our Ref: 4191-1 FSCA Dear Valued bioMrieux Customer, Our records indicate that your laboratory uses the VITEK 2 System in conjunction with the VITEK 2 AST-N351 test kit. Description of Issue: bioMrieux has received reports from VITEK 2 customers that an unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype has been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N351 (ref. 421257) test kit. When an ESBL phenotype is proposed by VITEK 2 Systems Software AES (Advanced Expert System), the result is stopped for review by the user. The intent of the review is that the laboratory personnel take measures to confirm the proposed ESBL phenotype makes sense based on all information available, and perform confirmatory testing if deemed appropriate. Internal bioMrieux investigations concluded that within the VITEK 2 Systems Software version 8.01/9.01 AES (Advanced Expert System) module, the MIC (Minimum Inhibitory Concentration) ranges for Escherichia coli and pipericillin/tazobactam were changed for the Acquired Penicillinase and Inhibitor Resistant Penicillinase phenotypes. These changes consisted of removing MICs >=128 mg/L as possible MICs for both phenotypes. This change revealed an issue in the AES definition of the cefuroxime MIC range for Escherichia coli and ESBLs (the MIC range is too broad; cefuroxime MIC <=8 mg/L should prevent the ESBL phenotype proposal). This, in addition to the specific antibiotic configuration of the AST-N351 card and absence of the ESBL test, is the root cause of the reported increase in ESBL phenotype proposal for the AST-N351 card. Implementation of a bioART" rule with the following criteria will prevent inappropriate proposal of the ESBL phenotype related to this anomaly (reference Appendix A for detailed instructions): " If the card is AST-N351 " And the ph
Quantity in commerce: 30,292 cartons (20 cards per carton)
Distribution: UK and Ireland
Product codes and lots: Ref: 421257 ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0847-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0847-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-16

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)