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i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37...

FDA Recall #Z-1974-2012 — Class II — September 8, 2011

Recall #Z-1974-2012 Date: September 8, 2011 Classification: Class II Status: Terminated

Product Description

i-Stat Portable Clinical 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 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

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

06F16-02-1295 UNITS; 210000-1076 UNITS; 210001-447 UNITS; 210002-5359 UNITS; 210003-9051 UNITS

Distribution

Worldwide Distribution - USA (nationwide)

Code Information

i-Stat Portable Clinical Analyzer 06F16-02 210000 210001 210002 210003 All lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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