TEM Systems

3 recalls •

🏥 Medical Devices

• Categories: Diagnostic Equipment, Other Medical Devices

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.

Class I - Dangerous

Customers complained of low/empty reagent vials.

Sep 13, 2016 Diagnostic Equipment Nationwide View Details →

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.

Class I - Dangerous

Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.

Feb 18, 2016 Diagnostic Equipment Nationwide View Details →

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

Class I - Dangerous

Some of vials were found to be partially filled.

Oct 23, 2014 Other Medical Devices Nationwide View Details →