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.
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- July 18, 2014
- Posted
- September 16, 2014
- Terminated
- January 16, 2015
- Recall Number
- Z-2650-2014
- Quantity
- 514 kits
- Firm Location
- Parsippany, NJ
Reason for Recall
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
Distribution
Distributed USA (nationwide) and the country of Canada.
Lot / Code Info
510(k) #K111822, Lot #112366, Part # REF 00311US
Root Cause
Under Investigation by firm
Action Taken
Diagnostica Stago sent a "Quality Information" letter/Customer Acknowledgement form to its customers. The letter identified the product, problem, and actions to be taken by the customers. For additional information and further support contact the Diagnostica Stago Hotline at 800-725-0607.
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