BEUDAMED
    FDA Recall Terminated

    API 50 CH, Model 50300

    Recall: Z-0243-2022 · Initiated September 30, 2021

    Recall

    Recall Number
    Z-0243-2022
    Event Number
    88844
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    JSC
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 30, 2021
    Terminated
    January 18, 2024
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    API 50 CH, Model 50300

    Reason

    There is potential to provide an incorrect organism identification.

    Action

    Notification letters were issued to customers via FedEx Priority Overnight mail during the week of October 4, 2021. Customers are asked to do the following: -Discontinue use of and discard any remaining inventory of lot 1008679230. -For tests previously performed using API 50 CH Ref. 50300 lot# 1008679230, we are asking you to identify any possible incorrect identification test result due to a false positive reaction of test 34, analyze the related risks and to determine appropriate actions, if relevant. -Complete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. -Distribute this information to all appropriate personnel in the laboratory, retain a copy in your files. -Contact your local bioMrieux representative for product compensation. Consignees will perform destruction activities at their site.

    Distribution

    Distribution in WI, NY, and SD

    Quantity

    1382 kits