FDA-Device2012-07-18Class II

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

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
6000-0000-650 units
Manufactured in
400 College Rd E, Princeton, NJ, United States
Products
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1976-2012

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