Recall Z-2361-2015 ยท GJS Test, Time, Prothrombin
Abbott Point Of Care Inc.
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.
| Date | Aug 10, 2015 (initiated Jun 15, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| 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, Pola |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020355 | I-STAT PROTHROMBIN TIME TEST I-Stat Corporation, May 14, 2002 |