CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division
FDA device recall Z-0639-2007 · posted 2007-03-16 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
- Action taken
- On May 12, 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
- 6,893 units
- Distribution
- Class II- Worldwide Distribution-USA including the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, WA, WI, and WV and countries of
- Date initiated
- 2004-05-12
- Date posted
- 2007-03-16
- 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 4000 SYSTEM (K961439) | Abbott Diagnostics | 1996-10-18 |