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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 Recall
STA Satellite Automated MultiParameter Analyzer
see related information
Date Posted November 06, 2012
Recall Status1 Terminated on July 19, 2013
Recall Number Z-0252-2013
Recall Event ID 63270
Premarket Notification
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, New Jersey 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JPA and Original Applicant = DIAGNOSTICA STAGO, INC.
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