i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Point of Care Inc. 104 Win
FDA device recall Z-0364-2007 · posted 2007-01-23 · Terminated
Recall details
- Recalling firm
- Abbott Point of Care Inc.
- Reason for recall
- Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.
- Action taken
- Customers were notified by letter sent by regular mail on 12/13/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 14,045 boxes of 24
- Distribution
- Nationwide to hospitals and health care facilities
- Date initiated
- 2006-12-12
- Date posted
- 2007-01-23
- Date terminated
- 2007-08-15
- 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 PROTHROMBIN TIME TEST (K020355) | I-Stat Corporation | 2002-05-14 |