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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KFF
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