Recall Z-0708-2007 ยท GIF Diluent, Blood Cell
Abbott Laboratories
CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
| Date | Apr 3, 2007 (initiated Apr 17, 2006) |
| Status | Terminated |
| Reason | High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range. |
| Root cause | Other |
| Action | On 4/17/06, the firm initiated the recall and its notification letters explained the reason for the recall and reported Abbott Field Service personnel will install and replace filters at all recall sites |
| Quantity | 56,075 units |
| Distribution | Worldwide Distribution-USA including states of AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV and Countriers of Argentina, Australia, Brazil, Hong Kong, Panama, Peru, Puerto Rico, Sin |
| FDA record | Open on fda.gov |