Device 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.
Z-2650-2014
Product summary
- Event
- Event 69070
- Status
- Terminated
- Classification
- Class III
- Quantity
- 514 kits
- Official record key
device-enforcement:Z-2650-2014
Official wording
Reason: Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
Code information: 510(k) #K111822, Lot #112366, Part # REF 00311US
Distribution pattern: Distributed USA (nationwide) and the country of Canada.
Derived failure modes
-
Unknown
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.