Abbott Point Of Care Inc.: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. ; Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

Agency Publication Date: July 9, 2012

Affected Products

Product: 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 s

510K K940918 Product Number/List Number 06F16-05; 06F16--10; 310000; 310001;; 310002 All lots

Product: 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

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

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

FUSO Analyzer 300F 310003 All lots

Product: i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

i-Stat1 Abaxis Analyzer 6000-0000 All lots

Product: 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

Military Kit iStat1 04J48-201 215001 All lots

Product: Military Kit 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 cartrid

Military Kit Portable Clinical Analyzer 04J48-01 215000 All lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62319

Status: Resolved

Manufacturer: Abbott Point Of Care Inc.

Manufactured In: United States

Units Affected: 6 products (06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; 310001-1139 units; 310002-11489 units; 06F16-02-1295 UNITS; 210000-1076 UNITS; 210001-447 UNITS; 210002-5359 UNITS; 210003-9051 UNITS; 310003 -2203 units; 6000-0000-650 units; 04J48-201-1069 units; 215001-217 units; 04J48-01-56 units; 215000-695 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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