i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
FDA device recall Z-0912-05 · posted 2005-06-21 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
- Action taken
- The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.
- Root cause
- Other
- Status
- Terminated
- Product code
- JBP
- Quantity affected
- 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, Hon
- Date initiated
- 2005-03-16
- Date posted
- 2005-06-21
- Date terminated
- 2006-06-30
- Location
- East Windsor, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT SYSTEM (K992571) | I-Stat Corp. | 2000-02-10 |