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U.S. Department of Health and Human Services

Class 2 Device Recall STA System Control NP

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  Class 2 Device Recall STA System Control NP see related information
Date Initiated by Firm August 23, 2011
Date Posted February 16, 2012
Recall Status1 Terminated 3 on September 04, 2013
Recall Number Z-1044-2012
Recall Event ID 61019
510(K)Number K943518  
Product Classification Plasma, coagulation control - Product Code GGN
Product STA - System Control N + P

Product Usage:
The STA¿ -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STA¿brand name suitable to these reagents: -the Reagent 1 (STA¿-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase¿¿ time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA¿¿ -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase¿¿ time. Do not use the STA¿¿ -System Control N+P kit on STA Satellite¿ for the control of the APTT performed with the STA¿¿-rTT kit.
Code Information K9483518 D029396 Lot #106775
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact STAGO Hotline
800-725-0607
Manufacturer Reason
for Recall		 Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Stago sent a recall letters via email dated August 23, 2011 to all affected customers . The letter identified the product, description of problem, and corrective actions to be taken. Customers were asked to immediately examine their inventory and follow the corrective actions provided. Customers were instructed to complete the response form attached to the letter. Because of incorrect manufacturer's instructions included in the initial letter another letter was emailed by the firm on August 30, 2011. For questions or technical assistance for updating the parameters please call the Diagnostica Stago 24 hour hotline at 1-800-725-0607.
Quantity in Commerce 1259 units
Distribution Worldwide Distribution and USA (Nationwide) and including 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 = GGN and Original Applicant = AMERICAN BIOPRODUCTS CO.
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