Abbott Point Of Care Inc.: Medical Device Recall in 2012 - (Recall #: Z-2157-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 1, 2012

Date Posted: August 15, 2012

Recall Number: Z-2157-2012

Event ID: 62536

Reason for Recall:

The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.

Status: Terminated

Product Quantity: 2,950,296 cartridges US; 156,408 cartridges OUS

Code Information:

List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12

Distribution Pattern:

Worldwide Distribution -- (USA) nationwide

Voluntary or Mandated:

Voluntary: Firm initiated