i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
FDA Recall #Z-1976-2012 — Class II — September 8, 2011
Product Description
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Reason for Recall
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Recalling Firm
Abbott Point Of Care Inc. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6000-0000-650 units
Distribution
Worldwide Distribution - USA (nationwide)
Code Information
i-Stat1 Abaxis Analyzer 6000-0000 All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated