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Haemonetics Corporation recalls TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Recalled July 31, 2013 · FDA recall Z-1796-2013 · Haemonetics
Hazard
Research Use Only (RUO) parameters were included in TEG 5000 User Manual. · FDA Class II
Units
1590 devices
Sold at
US Nationwide
Description
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Product
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Manufacturer(s)
Haemonetics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →