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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Recall Number Z-1976-2012
Classification Class II
Code Info i-Stat1 Abaxis Analyzer 6000-0000 All lots
Product Distributed Qty 6000-0000-650 units
Reason For Recall Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

Event Detail

Event Id 62319
Product Type Devices
Status Ongoing
Recalling Firm Abbott Point Of Care Inc.
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide)