Device 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.
Z-0252-2013
Product summary
- Event
- Event 63270
- Status
- Terminated
- Classification
- Class II
- Quantity
- 232 units US; 5 units Canada
- Official record key
device-enforcement:Z-0252-2013
Official wording
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¿.
Code information: K082248 D089976 Ref 58104 units
Distribution pattern: Worldwide Distribution - USA (nationwide) and Canada
Derived failure modes
-
Unknown
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¿.