Recall Z-2361-2015
Abbott Point Of Care Inc. · initiated June 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.
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.
FDA-determined cause: Under Investigation by firm
Action taken
Abbott Point of Care sent a recall letter dated June 15, 2015 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the enclosed Business Reply Card (BRC). A Proof of Destruction From (FG-4533 in included with letter and is required to be returned to APOC as part of the credit process. Customers with questions were instructed to contact APOC Technical Support at 800-366-8020, Option 1 or their APOC representative.
Details
- Recall number
- Z-2361-2015
- Initiated
- June 15, 2015
- Posted by FDA
- August 10, 2015
- Terminated
- February 19, 2016
- Product code
- GJS – Test, Time, Prothrombin
- Quantity
- 423,168 cartridges
- Distribution
- 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.
- Recalling firm
- Abbott Point Of Care Inc., Princeton, NJ