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Abbott Point Of Care Inc. recalls Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, i
Recalled July 18, 2012 · FDA recall Z-1975-2012 · Abbott Point Of Care
Hazard
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. · FDA Class II
Units
310003 -2203 units
Sold at
Worldwide Distribution - USA (nationwide)
Description
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Product
Fuso Analyzer 300F; 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 510 K940918 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. 510K 001387
Manufacturer(s)
Abbott Point Of Care Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →