BEUDAMED
    FDA Recall 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 · Initiated February 15, 2012

    Recall

    Recall Number
    Z-2116-2017
    Event Number
    76985
    Firm
    Medtest Holdings, Inc.
    FEI Number
    1827821
    Product Code
    CIT
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 15, 2012
    Posted
    May 18, 2017
    Terminated
    June 2, 2017
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    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.

    Action

    Technical Bulletin Notification letter was sent 02/15/12 by email to all customers and distributors. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-757-5313.

    Distribution

    US Nationwide Distribution

    Quantity

    119.168L across All lots