TEM Systems Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0302-2017Class IIex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monSeptember 13, 2016
Z-1090-2016Class IIROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. QualiFebruary 18, 2016
Z-1379-2015Class IIROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.October 23, 2014