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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 ASTN351 Test Kit

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  Class 2 Device Recall VITEK 2 ASTN351 Test Kit see related information
Date Initiated by Firm December 13, 2018
Create Date February 16, 2019
Recall Status1 Terminated 3 on August 16, 2021
Recall Number Z-0847-2019
Recall Event ID 81953
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product VITEK 2 AST-N351 Test Kit
Code Information Ref: 421257 ALL LOTS
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact
919-620-2000
Manufacturer Reason
for Recall		 False Positive ESBL Phenotype
FDA Determined
Cause 2		 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 bioM¿rieux 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: bioM¿rieux 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 bioM¿rieux 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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