BEUDAMED
    FDA Enforcement Class II Terminated

    AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.

    Recall: Z-0671-2019 · Reported January 2, 2019

    Enforcement

    Recall Number
    Z-0671-2019
    Event ID
    81597
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2019
    Initiation Date
    November 30, 2018
    Classification Date
    December 22, 2018
    Termination Date
    January 14, 2021
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895, United States

    Description

    AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.

    Reason

    Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays

    Code Info

    all lots

    Distribution

    US Nationwide

    Quantity

    29645 units