Recall Z-0639-2007 ยท GIF Diluent, Blood Cell
Abbott Laboratories
CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
| Date | Mar 16, 2007 (initiated May 12, 2004) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 Argentina, Brazil, Hong Kong, Japan, Malaysia, Singapore, Taiwan, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961439 | ABBOTT CELL-DYN 4000 SYSTEM Abbott Diagnostics, Oct 18, 1996 |