Recall Z-0252-2013 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Diagnostica Stago, Inc.
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.
| Date | Nov 6, 2012 (initiated Jun 15, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 232 units US; 5 units Canada |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER Diagnostica Stago, Inc., Dec 12, 2008 |