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    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.

    FDA Recall
    Terminated ·TEM Systems Inc·Product code JPA·September 13, 2016

    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.

    FDA Recall
    Terminated ·TEM Systems Inc·Product code GGN·February 18, 2016

    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

    FDA Recall
    Terminated ·TEM Systems Inc·Product code JPA·October 23, 2014