BEUDAMED
    FDA Recall Terminated

    TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System

    Recall: Z-2742-2011 · Initiated March 4, 2011

    Recall

    Recall Number
    Z-2742-2011
    Event Number
    58847
    Firm
    Haemoscope Division of Haemonetics Corp
    FEI Number
    2429444
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2011
    Posted
    July 6, 2011
    Terminated
    September 25, 2012
    Address
    6231 W Howard St, Niles, IL, 60714-3403

    Description

    TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System

    Reason

    Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).

    Action

    Haemoscope, a Division of Haemonetics Corp, sent a letter dated March 2, 2011 to all of the affected customers. The letters informed the customers that Haemoscope had received a higher than normal inquiry rate for the Level II Quality Control Kits, part 07-008, lots HMO196 and HMO 197. The accounts were requested to return their stocks of those two lots for further testing and evaluation and to complete the enclosed acknowledgement form, confirming receipt of the letter and the number of kit boxes being returned, and fax it back to Haemoscope at 847-588-0455. The returned kits will be replaced at no charge. For additional information please contact Haemoscope at 847-588-0453, ext-217 .

    Distribution

    Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines

    Quantity

    568 kits