CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott D
FDA device recall Z-0708-2007 · posted 2007-04-03 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.
- Action taken
- On 4/17/06, the firm initiated the recall and its notification letters explained the reason for the recall and reported Abbott Field Service personnel will install and replace filters at all recall sites
- Root cause
- Other
- Status
- Terminated
- Product code
- GIF
- Quantity affected
- 56,075 units
- Distribution
- Worldwide Distribution-USA including states of AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, W
- Date initiated
- 2006-04-17
- Date posted
- 2007-04-03
- Date terminated
- 2007-11-28
- 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 |
|---|---|---|
| CELL-DYN SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |
| ABBOTT CELL-DYN 4000 SYSTEM (K961439) | Abbott Diagnostics | 1996-10-18 |