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.
This recall has been terminated (originally issued August 8, 2012).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- March 1, 2012
- Posted
- August 8, 2012
- Terminated
- February 8, 2013
- Recall Number
- Z-2157-2012
- Quantity
- 2,950,296 cartridges US; 156,408 cartridges OUS
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Distribution
Worldwide Distribution -- (USA) nationwide
Lot / Code Info
List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12
Root Cause
Process control
Action Taken
Abbott Point of Care Inc, sent a URGENT RECALL NOTICE dated March 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were provided in the letter with instructions in the letter on how to handle the affected product. Please complete and return the enclosed Business Reply card to acknowledge receipt of this communication and installation of the interium software CLEW and also 1) Update all handhelds 2) download appropriate assignment sheets. For further questions please call (609) 454-9000.