Device product
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.
Z-2157-2012
Product summary
- Event
- Event 62536
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,950,296 cartridges US; 156,408 cartridges OUS
- Official record key
device-enforcement:Z-2157-2012
Official wording
Reason: The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Code information: List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12
Distribution pattern: Worldwide Distribution -- (USA) nationwide
Derived failure modes
-
Unknown
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.