Abbott Point Of Care Inc. recalls i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 2…

Recall date

June 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2361-2015

FDA classification

Class II

Brand / firm

Abbott Point Of Care Inc.

Sold / distributed

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, Pola…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.