CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division,
FDA device recall Z-0706-2007 · posted 2007-04-03 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range
- Action taken
- On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.
- Root cause
- Other
- Status
- Terminated
- Product code
- GIF
- Quantity affected
- 27,411 units
- Distribution
- Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republ
- Date initiated
- 2004-09-29
- Date posted
- 2007-04-03
- Date terminated
- 2007-05-01
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT CELL-DYN 3200 SYSTEM (K972354) | Abbott Laboratories | 1997-09-16 |