Device Recall Stago IVD, Liquid AntiXa

510(k) #K111822, Lot #112366, Part # REF 00311US

Hematology and Pathology Devices

2

No

Distributed USA (nationwide) and the country of Canada.

Stago IVD, Liquid Anti-Xa, NDC 3607450003116. || The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.