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Diagnostica Stago, Inc. recalls STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and i
Recalled November 14, 2012 · FDA recall Z-0252-2013 · Diagnostica Stago
Hazard
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 Class II
Units
232 units US; 5 units Canada
Sold at
Worldwide Distribution - USA (nationwide) and Canada
Description
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¿.
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.
Manufacturer(s)
Diagnostica Stago, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →