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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 & VITEK 2 Compact

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 Class 2 Device Recall VITEK 2 & VITEK 2 Compactsee related information
Date Initiated by FirmNovember 13, 2018
Create DateDecember 19, 2018
Recall Status1 Terminated 3 on July 07, 2021
Recall NumberZ-0639-2019
Recall Event ID 81589
510(K)NumberK050002 
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
ProductVITEK 2 Systems Software Version 9.01 Update Kit.
Code Information Product Description: KIT UPDT VTK2 9.01 EN,   UDI: 03573026561260
FEI Number 3002769706
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
Manufacturer Reason
for Recall		The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP" feature.
FDA Determined
Cause 2		Software design
ActionbioMerieux notified customers of the recall on about 11/13/2018 via "URGENT PRODUCT CORRECTION NOTICE." Instructions included taking the following actions: 1) Confirm the letter has been distributed to, and reviewed by, all appropriate personnel; 2) If appropriate in accordance with consignee's laboratory's Standard Operating Procedures, perform retrospective review of any patient results potentially impacted in relation to the described VITEK FLEXPREP anomaly; 3) Store this letter with the bioMrieux, Inc. VITEK 2 instrument documentation; 4) Complete and return the Acknowledgement Form in Attachment A to confirm receipt of the notice and return it to your local bioMrieux, Inc. representative. Regardless of each consignee's current use of the VITEK FLEXPREP" feature, your local Field Service Engineer has implemented the software solution on your VITEK 2 System. If you require additional assistance or have any questions, please contact your local bioMrieux, Inc. Clinical Customer Service representative at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at CustomerService-IDAST@biomerieux.com. The anticipated turnaround time for email inquiries is 24-48 hours during normal business hours (7AM  7PM EST), and up to 72 hours dependent upon weekends and company observed holidays.
Quantity in Commercefive (5) VITEK¿ 2 Systems Software version 9.01
DistributionNationwide distribution to CO, IL, MO, TX.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = LON
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