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U.S. Department of Health and Human Services

Class 2 Device Recall Biomerieux Vitek 2 Test kit

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  Class 2 Device Recall Biomerieux Vitek 2 Test kit see related information
Date Initiated by Firm March 15, 2019
Create Date April 12, 2019
Recall Status1 Terminated 3 on August 17, 2021
Recall Number Z-1137-2019
Recall Event ID 82501
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
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.
Code Information 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)
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact
919-620-2000
Manufacturer 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.
FDA Determined
Cause 2		 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 bioM¿rieux instrument documentation. ¿ Complete the Acknowledgement Form and return it to your local bioM¿rieux representative. bioM¿rieux, 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 bioM¿rieux representative."
Quantity in Commerce 10784 cartons
Distribution Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.
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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