Recall Z-0400-2011 ยท JBP Activated Whole Blood Clotting Time
Abbott Point Of Care Inc.
i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
| Date | Nov 17, 2010 (initiated Oct 6, 2010) |
| Status | Terminated |
| Reason | Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge. |
| Root cause | Other |
| Action | Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material. Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch t |
| Quantity | 95,325 cartridges |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023582 | I-STAT KAOLIN ACT TEST I-Stat Corporation, Sep 8, 2003 |