Device product
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Z-1976-2012
Product summary
- Event
- Event 62319
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6000-0000-650 units
- Official record key
device-enforcement:Z-1976-2012
Official wording
Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Code information: i-Stat1 Abaxis Analyzer 6000-0000 All lots
Distribution pattern: Worldwide Distribution - USA (nationwide)
Derived failure modes
-
Unknown
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.