Z-2361-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2015
- Initiation Date
- June 15, 2015
- Termination Date
- February 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 423,168 cartridges
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.
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.
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.
Code Information
All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.