BEUDAMED
    FDA Recall Terminated

    Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.

    Recall: Z-0921-2012 · Initiated June 27, 2011

    Recall

    Recall Number
    Z-0921-2012
    Event Number
    60811
    Firm
    Catch Incorporated
    FEI Number
    3005002431
    Product Code
    LPS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 27, 2011
    Posted
    January 27, 2012
    Terminated
    July 11, 2012
    Address
    11822 N Creek Pkwy N, Ste 107, Bothell, WA, 98011-8203

    Description

    Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.

    Reason

    Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had prematurely decayed.

    Action

    Catch Inc. sent an "URGENT-PRODUCT RECALL" letter dated 27 June 2011 to one sole customer. The letter described the product, problem, and actions to be taken by the customer. A reply form was attached to the letter for the customer to complete and return via fax at 425-402-8954. Please contact the firm at 425-402-8960 for questions regarding this recall.

    Distribution

    Product distributed in PA.

    Quantity

    47 kits