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U.S. Department of Health and Human Services

Class 3 Device Recall Stago IVD, Liquid AntiXa

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  Class 3 Device Recall Stago IVD, Liquid AntiXa see related information
Date Initiated by Firm July 18, 2014
Date Posted September 16, 2014
Recall Status1 Terminated 3 on January 16, 2015
Recall Number Z-2650-2014
Recall Event ID 69070
510(K)Number K111822  
Product Classification Assay, heparin - Product Code KFF
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.
Code Information 510(k) #K111822, Lot #112366, Part # REF 00311US
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact Mr. Stephane Zamia, Ph.D.
973-352-8800
Manufacturer Reason
for Recall		 Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 514 kits
Distribution Distributed USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KFF and Original Applicant = DIAGNOSTICA STAGO, INC.
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