Abbott Point Of Care Inc.: Medical Device Recall in 2013 - (Recall #: Z-0451-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

Product Classification:

Class II

Date Initiated: October 28, 2013

Date Posted: December 11, 2013

Recall Number: Z-0451-2014

Event ID: 66757

Reason for Recall:

Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.

Status: Terminated

Product Quantity: 794,928 units US; 119,472 units OUS

Code Information:

K020355 List number 04J50-01, 04J50-02; 03P89-24 Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,

Voluntary or Mandated:

Voluntary: Firm initiated