TEM Systems Recalls
3 recalls on record · April 15, 2015 to November 2, 2016 · Medical Devices
Recalls by year
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 2, 2016Medical DevicesFDA
TEM Systems Inc recalls ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation
Hazard: Customers complained of low/empty reagent vials.
March 16, 2016Medical DevicesFDA
TEM Systems Inc recalls ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material
Hazard: 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.
April 15, 2015Medical DevicesFDA
TEM Systems Inc recalls ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Hazard: Some of vials were found to be partially filled.