American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
FDA device recall Z-0779-2007 · posted 2007-05-03 · Terminated
Recall details
- Recalling firm
- American Diagnostica, Inc.
- Reason for recall
- Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas
- Action taken
- American Diagnostica notified accounts by letter on 2/28/07 and 3/02/07 and international distributors on 2/28/07. Users are requested to discontinue use and destroy. Kits will be replaced.
- Root cause
- Other
- Status
- Terminated
- Product code
- GIR
- Quantity affected
- 249 kits
- Distribution
- Worldwide, including USA, Canada, Germany, UK, Italy, Israel, Greece, and the Netherlands.
- Date initiated
- 2007-02-28
- Date posted
- 2007-05-03
- Date terminated
- 2016-07-06
- Location
- Stamford, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTICLOT, MODEL 824 (K052124) | American Diagnostica, Inc. | 2005-10-17 |