BEUDAMED
    FDA Recall Open, Classified

    VIDAS RUB IgG (RBG), REF 30226

    Recall: Z-0432-2022 · Initiated September 22, 2021

    Recall

    Recall Number
    Z-0432-2022
    Event Number
    88797
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    LFX
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 22, 2021
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    VIDAS RUB IgG (RBG), REF 30226

    Reason

    bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

    Action

    For products with No remaining shelf life (taking into account the revised expiration date): - Identify impacted lots - Stop using the listed impacted lots - Destroy the remaining impacted lots in your inventory For products with remaining shelf life (taking into account the revised expiration date): - Identify impacted products and lots listed - Update product expiration date per your internal procedures of the remaining usable lots to meet the new revised expiration date specified in Table 1 - Continue product use until the revised expiration date. Consignees are asked to distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom you may have transferred affected product. Complete the Acknowledgement Form in Attachment A and return it to [email protected] or Fax to: (919) 620-3306 to confirm receipt of this notice.

    Distribution

    US Nationwide distribution.

    Quantity

    Three lots