STA Satellite Automated Multi-Parameter Analyzer This recall
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of…
Why was STA Satellite Automated Multi-Parameter Analyzer This recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
K082248 D089976 Ref 58104 units
- Product
- STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of…
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 232 units US; 5 units Canada
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada
- Recall date
- November 14, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)