bioMerieux, Inc.: VITEK 2 AST-N351 Test Kit

Recall number

Z-0847-2019

Recalling firm

bioMerieux, Inc.

Product

VITEK 2 AST-N351 Test Kit

Status

Terminated

Initiated

2018-12-13

Posted

not on file

Terminated

2021-08-16

Reason

False Positive ESBL Phenotype

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

30,292 cartons (20 cards per carton)

Distribution

UK and Ireland

Lot, serial or model codes

Ref: 421257 ALL LOTS

510(k) numbers

not on file

PMA numbers

not on file

Product code

LON

Firm FEI

3002769706

Firm city

Durham

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy