Recall Z-1796-2013— Haemonetics Corporation

Name: FDA recall Z-1796-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-20

Class II · Terminated

Class II FDA medical device recall by Haemonetics Corporation, initiated 2013-06-20, terminated 2015-06-04. It names one FDA 510(k) clearance: K002177. Product: TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies. Reason: Research Use Only (RUO) parameters were included in TEG 5000 User Manual..

Recalling firm: Haemonetics Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-06-20
Terminated: 2015-06-04
Firm location: Braintree, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K002177 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESHaemoscope Corp.·cleared 2000-09-14

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

TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

Reason for recall

Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

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