Recall Z-2485-2019— Instrumentation Laboratory Co.

Name: FDA recall Z-2485-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-23

Class II · Terminated

Class II FDA medical device recall by Instrumentation Laboratory Co., initiated 2019-07-23, terminated 2020-04-27. It names one FDA 510(k) clearance: K101533. Product: ROTEM ex-tem; US Part No: 503-05-US. Reason: Prolonged clotting times.

Recalling firm: Instrumentation Laboratory Co.
Classification: Class II
Status: Terminated
Initiated: 2019-07-23
Terminated: 2020-04-27
Firm location: Bedford, MA, 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

ROTEM ex-tem; US Part No: 503-05-US

Reason for recall

Prolonged clotting times

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