BEUDAMED
    FDA Recall Open, Classified

    Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

    Recall: Z-1016-2023 · Initiated December 6, 2022

    Recall

    Recall Number
    Z-1016-2023
    Event Number
    91344
    Firm
    Future Diagnostics Solutions B.V. Nieuweweg 279 Wijchen Netherlands
    FEI Number
    3001857593
    Product Code
    CEW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 6, 2022
    Posted
    January 25, 2023

    Description

    Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

    Reason

    Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.

    Action

    On 12/06/2022, the firm send a Recall Notice via email to customer informing them that The PTH kit 4K-IPT-00 with lot numbers: M78559, M78560 and M78636 can occasionally give a high duplicate %CV outside the recommended maximum of 15%CV. As a result of the failure in the duplicate CV requires a repeat run it may cause a delay in the patient result turnaround time or in system calibration depending on what samples are run and can lead to a wrong sample result. Actions to be taken by customers: -Immediately identify and quarantine the affected lot numbers. -Further instructions will be provided by the Future Diagnostics. For questions, send an email to [email protected].

    Distribution

    Worldwide distribution. US states of AZ, CA, CO, LA, OH, PA, and TX; Austria, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden, and United Kingdom

    Quantity

    342 kits