FDAFDA · Food and drugs·Recall number Z-2650-2014
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.
Published September 24, 2014 · Recall initiated: July 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Diagnostica Stago, Inc.
- Distributor
- Distributed USA (nationwide) and the country of Canada.
- Lot
- 510(k) #K111822, Lot #112366, Part # REF 00311US
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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