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
This recall has been terminated (originally issued April 3, 2007).
- Company
- Abbott Laboratories
- Recall Initiated
- April 17, 2006
- Posted
- April 3, 2007
- Terminated
- November 28, 2007
- Recall Number
- Z-0708-2007
- Quantity
- 56,075 units
- Firm Location
- Santa Clara, CA
- Official Source
- View on FDA website ↗
Reason for Recall
High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.
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, Singapore, South Korea, Taiwan, and Venezuela.
Lot / Code Info
All lots
Root Cause
Other
Action Taken
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