BEUDAMED
    FDA Recall Terminated

    A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis

    Recall: Z-0349-2023 · Initiated October 5, 2021

    Recall

    Recall Number
    Z-0349-2023
    Event Number
    91054
    Firm
    Primus Corporation dba Trinity Biotech
    FEI Number
    1931251
    Product Code
    JPK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 5, 2021
    Posted
    December 1, 2022
    Terminated
    August 9, 2023
    Address
    4231 E 75th Ter, Kansas City, MO, 64132-2059

    Description

    A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis

    Reason

    The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.

    Action

    The firm sent an Urgent Filed Safety Notice their consignees on 10/05/2021 by mail. The notice explained the issue, risk and requested the destruction of of the affected devices.

    Distribution

    Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.

    Quantity

    340 kits