Enforcement Report - Week of July 18, 2012
-
Back to Previous Page
Product Detail
| Product Description | iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. |
|---|---|
| Recall Number | Z-1973-2012 |
| Classification | Class II |
| Code Info | 510K K940918 Product Number/List Number 06F16-05; 06F16--10; 310000; 310001;; 310002 All lots |
| Product Distributed Qty | 06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; 310001-1139 units; 310002-11489 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) |
-
