Recall Z-1090-2016— TEM Systems Inc

Name: FDA recall Z-1090-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-18

Class II · Terminated

Class II FDA medical device recall by TEM Systems Inc, initiated 2016-02-18, terminated 2016-06-30. It names one FDA 510(k) clearance: K083842. Product: 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.. Reason: 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..

Recalling firm: TEM Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Terminated: 2016-06-30
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K083842 — ROTEM DELTA THROMBOELASTOMETRY SYSTEMPentapharm GmbH·cleared 2010-03-23

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

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.

Reason for recall

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.

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