Abbott Point Of Care Inc.: Medical Device Recall in 2015 - (Recall #: Z-2361-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.

Product Classification:

Class II

Date Initiated: June 15, 2015

Date Posted: August 19, 2015

Recall Number: Z-2361-2015

Event ID: 71665

Reason for Recall:

Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.

Status: Terminated

Product Quantity: 423,168 cartridges

Code Information:

All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated