BEUDAMED
    FDA Recall Terminated

    Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

    Recall: Z-2434-2019 · Initiated October 14, 2016

    Recall

    Recall Number
    Z-2434-2019
    Event Number
    81383
    Firm
    Helena Laboratories, Inc.
    FEI Number
    1618982
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 14, 2016
    Terminated
    October 12, 2023
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    Description

    Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

    Reason

    Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.

    Action

    Between 10/14/2016 to 10/21/2016 a notification was emailed to the affected users informing them that Assay protocol had changed due to a Marketing decision to delete use of EDC, since it was a discontinued device (for over 10 years), creating a tighter assay range, but met QC specification. Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range, Technical Services began an MRA investigation. Investigation verified user complaint, and Lot was quarantined, and Rework action plans using EDC also were initiated for the device. This issue was found at a Users site, via use as system Quality Control material. The investigation focused on potential effects/risks, and cause. This issue was found at a Users site, via use as system Quality Control material. Customers reported a narrow assay range when compared to prior lots forcing some users out of the provided assay range. PUBLIC CONTACT: Title: Technical Services Manager Address: 1530 Lindbergh Drive, Beaumont, TX 77707 Telephone #: (409) 842-3714 x1177 Email: [email protected]

    Distribution

    Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea

    Quantity

    65 kits