FDAFDA · Food and drugs·Recall number Z-2157-2012
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.
Published August 15, 2012 · Recall initiated: March 1, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Point Of Care Inc.
- Distributor
- Worldwide Distribution -- (USA) nationwide
- Lot
- List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States