BEUDAMED
    FDA Recall Terminated

    STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAbrand name suitable to these reagents: -the Reagent 1 (STA-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase time. Do not use the STA -System Control N+P kit on STA Satellite for the control of the APTT performed with the STA-rTT kit.

    Recall: Z-1044-2012 · Initiated August 23, 2011

    Recall

    Recall Number
    Z-1044-2012
    Event Number
    61019
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GGN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 23, 2011
    Posted
    February 16, 2012
    Terminated
    September 4, 2013
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAbrand name suitable to these reagents: -the Reagent 1 (STA-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase time. Do not use the STA -System Control N+P kit on STA Satellite for the control of the APTT performed with the STA-rTT kit.

    Reason

    Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.

    Action

    Stago sent a recall letters via email dated August 23, 2011 to all affected customers . The letter identified the product, description of problem, and corrective actions to be taken. Customers were asked to immediately examine their inventory and follow the corrective actions provided. Customers were instructed to complete the response form attached to the letter. Because of incorrect manufacturer's instructions included in the initial letter another letter was emailed by the firm on August 30, 2011. For questions or technical assistance for updating the parameters please call the Diagnostica Stago 24 hour hotline at 1-800-725-0607.

    Distribution

    Worldwide Distribution and USA (Nationwide) and including Canada

    Quantity

    1259 units