BEUDAMED
    FDA Recall Terminated

    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

    Recall: Z-0417-2015 · Initiated October 16, 2014

    Recall

    Recall Number
    Z-0417-2015
    Event Number
    69545
    Firm
    Diagnostic Hybrids Inc
    FEI Number
    1000122536
    Product Code
    JZH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 16, 2014
    Posted
    September 3, 2015
    Terminated
    September 3, 2015
    Address
    1055 E State St, Suite 100, Athens, OH, 45701-7911

    Description

    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

    Reason

    Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

    Action

    Quidel sent an Urgent Medical Device Recall letter dated October 16, 2014, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review their inventory and determine if they have of the affected product. If so, they should remove it from their inventory and destroy it immediately by discarding it into their normal biomedical waste stream. Complete the enclosed Certificate of Destruction. Upon receipt of the Certificate of Destruction, Quidel, will then schedule their shipment of replacement product. If consignees further distributed the affected product, they should identify the customers and provide them with the Urgent Medical Device Recall. Consignees were instructed to monitor and reconcile the quarantine of product with the customers as this information may need to be provided to the authorities. For questions regarding this recall call 740-589-3300. For technical support consignees should contact [email protected] or call 800-874-1517.

    Distribution

    Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.

    Quantity

    171