| Date Posted |
November 06, 2012 |
| Recall Number |
Z-0252-2013 |
| 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
|
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¿.
|
| 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 |
| |
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