Recall Z-0814-2010 ยท JBP Activated Whole Blood Clotting Time
Abbott Point of Care Inc.
Abbott 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 | Feb 23, 2010 (initiated Aug 18, 2009) |
| Status | Terminated |
| Reason | Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect. |
| Root cause | Labeling False and Misleading |
| Action | Abbott Point of Care issued an "Important Product Information" letter beginning August 18, 2009. Consignees were instructed on how to reconcile all affected product. For further information, contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1. |
| Quantity | 1,110,775 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 |