Recall Z-0640-2007 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 17, 2007 (initiated Feb 24, 2004) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Other |
| Action | 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 |
| Quantity | 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 countries of Australia, Argentina, Brazil, Hong Kong, Japan, Korea, Malaysia, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961439 | ABBOTT CELL-DYN 4000 SYSTEM Abbott Diagnostics, Oct 18, 1996 |