Recall Z-1996-2010 ยท GJS Test, Time, Prothrombin
Abbott Point of Care Inc.
i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
| Date | Jul 13, 2010 (initiated May 5, 2010) |
| Status | Terminated |
| Reason | A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received. |
| Root cause | Other |
| Action | Urgent recall notifications were sent on May 13 2010. Customers were instructed to discontinue use and to return the identified lots. Additional questions are directed to Abbott Point of Care Technical Support at 800-3668020, Option 1 or your Abbott Point of Care representative. |
| Quantity | 44976 in US, 3648 in rest of world. |
| Distribution | Worldwide distribution: Argentina, Hong Kong, China, Finland, Greece, India, Portugal, Russian Federation, Saudi Arabia, United Arab Emirates, Italy, Spain, Australia, Germany, UK, Sweden, The Netherlands, France, Canada. |
| 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 |