BEUDAMED
    FDA Enforcement Class III Terminated

    Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.

    Recall: Z-2116-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2116-2017
    Event ID
    76985
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtest Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 24, 2017
    Initiation Date
    February 15, 2012
    Classification Date
    May 18, 2017
    Termination Date
    June 2, 2017
    Address
    5449 Research Dr, Canton, MI, 48188-2261, United States

    Description

    Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.

    Reason

    A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.

    Code Info

    Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.

    Distribution

    US Nationwide Distribution

    Quantity

    119.168L across All lots