—#169023

Product

VITEK 2 Systems Software Version 9.01 Update Kit.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K050002
Affected lot / code info: Product Description: KIT UPDT VTK2 9.01 EN, UDI: 03573026561260

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

bioMerieux 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.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Nationwide distribution to CO, IL, MO, TX.

Timeline

Recall initiated: 2018-11-13
Terminated: 2021-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.