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i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree te...

FDA Recall #Z-1977-2012 — Class II — September 8, 2011

Recall #Z-1977-2012 Date: September 8, 2011 Classification: Class II Status: Terminated

Product Description

i-STAT1 Abaxis 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

04J48-201-1069 units; 215001-217 units

Distribution

Worldwide Distribution - USA (nationwide)

Code Information

Military Kit iStat1 04J48-201 215001 All lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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