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Recall Observatory FDA recall evidence

Device product

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.

Z-2361-2015

June 15, 2015

Class II

Product summary

Firm
Abbott Point Of Care Inc.
Event
Event 71665
Status
Terminated
Classification
Class II
Quantity
423,168 cartridges
Official record key
device-enforcement:Z-2361-2015

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.