FDA-Device2012-07-18Class II
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
Abbott Point Of Care Inc.
Hazard
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sold states
Worldwide Distribution - USA (nationwide)
Affected count
06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; 310001-1139 units; 310002-11489 units
Manufactured in
400 College Rd E, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1973-2012Don't want to check this manually?
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