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.
Reported: August 15, 2012 Initiated: March 1, 2012 #Z-2157-2012
Product Description
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.
Reason for Recall
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Details
- Recalling Firm
- Abbott Point Of Care Inc.
- Units Affected
- 2,950,296 cartridges US; 156,408 cartridges OUS
- Distribution
- Worldwide Distribution -- (USA) nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Point Of Care Inc.. Units affected: 2,950,296 cartridges US; 156,408 cartridges OUS.
Why was this product recalled? ▼
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2012. Severity: Moderate. Recall number: Z-2157-2012.
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