Recall Z-2157-2012 ยท GJS Test, Time, Prothrombin
Abbott Point Of Care Inc.
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
| Date | Aug 8, 2012 (initiated Mar 1, 2012) |
| Status | Terminated |
| Reason | The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. |
| Root cause | Process control |
| Action | Abbott Point of Care Inc, sent a URGENT RECALL NOTICE dated March 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were provided in the letter with instructions in the letter on how to handle the affected product. Please complete and return the enclosed Business Reply card to acknowledge receipt of this communication and installation of the interium software CLEW and also 1) Update all handhelds 2) download appropriate assignment sheets. For further questions please call (609) 454-9000. |
| Quantity | 2,950,296 cartridges US; 156,408 cartridges OUS |
| Distribution | Worldwide Distribution -- (USA) nationwide |
| 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 |