FDA-Device2012-08-15Class II
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Abbott Point Of Care Inc.
Hazard
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Sold states
Worldwide Distribution -- (USA) nationwide
Affected count
2,950,296 cartridges US; 156,408 cartridges OUS
Manufactured in
400 College Rd E, Princeton, NJ, United States
Products
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2157-2012Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief