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) |
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