BEUDAMED
    FDA Recall Open, Classified

    Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.

    Recall: Z-2038-2023 · Initiated May 31, 2023

    Recall

    Recall Number
    Z-2038-2023
    Event Number
    92444
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    JSO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 31, 2023
    Posted
    June 29, 2023
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.

    Reason

    The test medium may not perform as intended.

    Action

    The firm issued recall letters dated 5/31/2023 via mail on 5/31/2023 that were flagged as URGENT: Deliver to Micro Lab. The letter provides the reason for the field action, risk to health, the product and distribution information, and actions to be taken by the customer. The actions included the consignee review reported results by an appropriate technical expert. The letter should be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products have been transferred. An Acknowledgement Form was enclosed for return to the firm via email. The form is for the consignee to acknowledge receipt of the recall notice and that it is understood, and the information and required actions have been brought to the attention of all relevant users and executed. The deadline for returning the form is 6/30/2023.

    Distribution

    Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.

    Quantity

    1,296 packs