CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 L
FDA device recall Z-0565-2007 · posted 2007-03-01 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
- Action taken
- Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.
- Root cause
- Other
- Status
- Terminated
- Product code
- GIF
- Quantity affected
- 652 (20 L. each) cubitainers
- Distribution
- Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.
- Date initiated
- 2006-12-22
- Date posted
- 2007-03-01
- 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 RUBY SYSTEM (K061667) | Abbott Laboratories | 2006-07-10 |
| CELL-DYN SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |
| ABBOTT CELL-DYN 4000 SYSTEM (K961439) | Abbott Diagnostics | 1996-10-18 |