Recall Z-1341-2011 ยท JBP Activated Whole Blood Clotting Time
Abbott Point Of Care Inc.
Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery organ transplantation and dialysis.
| Date | Feb 16, 2011 (initiated Dec 3, 2010) |
| Status | Terminated |
| Reason | Celite ACT cartridges have increased numbers of values outside the accepted allowable error. |
| Root cause | Device Design |
| Action | On behalf of Abbott, Genco Pharmaceutical Services sent an "URGENT RECALL NOTICE" dated November 2010, on December 3, 2010 via Fedex to all consignees/customers. Abbott sent out notification packages to foreign consignees/customers on December 3, 2010. The notice described the product, problem and action to be taken by customers. The firm recommended that customers use cartridges within 12 hours of removal from refrigerated storage based on the instructions provided with the product. The customers were instructed to complete and return the Business Reply cards to acknowledge receipt of the |
| Quantity | 1164275 cartridges |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992571 | I-STAT SYSTEM I-Stat Corp., Feb 10, 2000 |