BEUDAMED
    FDA Recall Terminated

    RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

    Recall: Z-1070-2018 · Initiated February 13, 2018

    Recall

    Recall Number
    Z-1070-2018
    Event Number
    79245
    FEI Number
    1616487
    Product Code
    DHR
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 13, 2018
    Terminated
    September 27, 2018
    Address
    1261 N Main St, Stanbio Laboratory, LP, Boerne, TX, 78006-3014

    Description

    RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

    Reason

    All patient serum samples yield a weakly positive test result.

    Action

    Recall notification letters were sent to affected consignees on 2/14/2018. The letter identified the affected product, problem and actions to be taken. The letter instructed the consignee to stop using affected products, quarantine products, and exchange the kit for an unaffected one.

    Distribution

    Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad

    Quantity

    686 units