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U.S. Department of Health and Human Services

Class 2 Device Recall STA Satellite Automated MultiParameter Analyzer

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  Class 2 Device Recall STA Satellite Automated MultiParameter Analyzer see related information
Date Initiated by Firm June 15, 2012
Date Posted November 06, 2012
Recall Status1 Terminated 3 on July 19, 2013
Recall Number Z-0252-2013
Recall Event ID 63270
510(K)Number K082248  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product STA Satellite Automated Multi-Parameter Analyzer

This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Code Information K082248 D089976 Ref 58104 units 
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		 Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿.
FDA Determined
Cause 2		 Software design
Action Diagnostica Stago sent an Urgent Field Safety Notice dated June 12, 2012, to all affected customers via email return receipt requested on June 15, 2012. Customers were instructed to follow the instructions in the notification and complete the Customer Verification form and return to the Hotline by fax to 973-644-9348. For additional information, customers were instructed to contact the Hotline at 800-725-0607. For questions regarding this recall call 973-631-1200, ext 2044.
Quantity in Commerce 232 units US; 5 units Canada
Distribution Worldwide Distribution - USA (nationwide) and 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 = JPA and Original Applicant = DIAGNOSTICA STAGO, INC.
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