Recall Z-0912-05 ยท JBP Activated Whole Blood Clotting Time
Abbott Laboratories
i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
| Date | Jun 21, 2005 (initiated Mar 16, 2005) |
| Status | Terminated |
| Reason | Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer. |
| Root cause | Other |
| Action | The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge. |
| Quantity | 298006 cartridges |
| Distribution | The cartridges have been distributed to hospitals and clinics nationwide. The cartridges have been distributed to Austria, Australia, Canada, Switzerland, China, Colombia, Germany, France, Greece, Hong Kong, India, New Zealand, and Singapore. There are 15 VA hospitals identified. There are 3 gov |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992571 | I-STAT SYSTEM I-Stat Corp., Feb 10, 2000 |