BEUDAMED
    FDA Recall Open, Classified

    AIM-V Medium REF AV.200/500

    Recall: Z-1643-2022 · Initiated July 7, 2022

    Recall

    Recall Number
    Z-1643-2022
    Event Number
    90654
    Firm
    OXFORD IMMUNOTEC LTD 143 Park Road Abingdon United Kingdom
    FEI Number
    3015492990
    Product Code
    OJN
    Status
    Open, Classified
    Root Cause
    Storage
    Initiated
    July 7, 2022

    Description

    AIM-V Medium REF AV.200/500

    Reason

    Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

    Action

    On 07/07/2022, Oxford Immunotec Limited send a Field Safety Notice to customers informing them that the firm has become aware that products distributed may have been stored outside of the storage specifications for a short period. Customer are asked to quarantined the affected products until further notice. On 07/13/2022, the firm communicated a follow-up "URGENT ACTION REQUIRED" Letter to customer asking to confirm that affected products have been segregated into a quarantine area and have not been used to produce patient results. On 07/20/2022, the firm sent a "VOLUNTARY PRODUCT RECALL NOTIFICATION" informing customers that Oxford Immunotec Limited is conducting a full recall of the affected products and asking customers to now destroy the affected products following these steps: 1. Ensure Recalled Product remains in Quarantine. As per our previous communication dated July-13-2022, please ensure all stock of the above products remain in a secure location pending destruction. 2. Complete Tracking/Verification Form. Complete and return the enclosed tracking/verification form, following the directions on this page and the Tracking/Verification Form. Your Oxford Immunotec sales representative can assist you in completing the form. 3. Indicate Destroyed Products on Tracking/Verification Form. The tracking/verification form lists the [product name] and product descriptions. Please mark the number of each type of [product] that you are destroying on this form. On or after 08/03/2022, Oxford Immunotec Ltd communicated an updated/follow-up customer notification with included the potential risks/harms/hazards associated with the use of the affected products. For questions or assistance - contact Chris Dark at +44 1235 442780 or Maureen Garner at 855-NWRS-222 (855-697-7222), or alternatively any Oxford Immunotec Sales Representatives.

    Distribution

    U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None

    Quantity

    6 units