FDAFDA · Food and drugs·Recall number Z-0252-2013
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.
Published November 14, 2012 · Recall initiated: June 15, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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¿.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Diagnostica Stago, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Canada
- Lot
- K082248 D089976 Ref 58104 units
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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