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
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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 = JPA and Original Applicant = DIAGNOSTICA STAGO, INC.
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