Recall Z-0302-2017— TEM Systems Inc

Name: FDA recall Z-0302-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-13

Class II · Terminated

Class II FDA medical device recall by TEM Systems Inc, initiated 2016-09-13, terminated 2017-12-05. It names one FDA 510(k) clearance: K101533. Product: 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.. Reason: Customers complained of low/empty reagent vials..

Recalling firm: TEM Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2016-09-13
Terminated: 2017-12-05
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K101533 — EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEMTem Innovations GmbH·cleared 2011-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Customers complained of low/empty reagent vials.

Data sourced from openFDA. This site is unofficial and independent of the FDA.