FDAFDA · Food and drugs·Recall number Z-1976-2012
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Published July 18, 2012 · Recall initiated: September 8, 2011
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
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Point Of Care Inc.
- Distributor
- Worldwide Distribution - USA (nationwide)
- Lot
- i-Stat1 Abaxis Analyzer 6000-0000 All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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