CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division
FDA device recall Z-0640-2007 · posted 2007-03-17 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Incorrect Test Results-product 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
- Recall Letter-On 2/24/04, the firm initiated the recall and its notification explaining the reason for the recall and requesting the product be destroyed
- Root cause
- Other
- Status
- Terminated
- Product code
- GIF
- Quantity affected
- 9,800 units
- Distribution
- Worldwide Distribution-USA including states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, lA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV. and count
- Date initiated
- 2004-02-24
- Date posted
- 2007-03-17
- 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 |