Medical DeviceNov 2, 2016
TEM Systems ex-TEM Assay for ROTEM delta Thromboelastometry System recall — FDA Z-0302-2017
Customers complained of low/empty reagent vials.
Class IIFDA: TerminatedTEM Systems Inc.
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceMar 16, 2016
TEM Systems ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro recall — FDA Z-1090-2016
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.
Class IIFDA: TerminatedTEM Systems Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies TEM Systems Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.