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Diagnostica Stago, Inc. recalls Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Comp
Recalled September 24, 2014 · FDA recall Z-2650-2014 · Diagnostica Stago
Hazard
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers. · FDA Class III
Units
514 kits
Sold at
Distributed USA (nationwide) and the country of Canada.
Description
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
Product
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.
Manufacturer(s)
Diagnostica Stago, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →