i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

FDA Recall #Z-1976-2012 — Class II — September 8, 2011

Recall #Z-1976-2012 Date: September 8, 2011 Classification: Class II Status: Terminated

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