CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
This recall has been terminated (originally issued March 17, 2007).
- Company
- Abbott Laboratories
- Recall Initiated
- February 24, 2004
- Posted
- March 17, 2007
- Terminated
- May 1, 2007
- Recall Number
- Z-0640-2007
- Quantity
- 9,800 units
- Firm Location
- Santa Clara, CA
- Official Source
- View on FDA website ↗
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).
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.
Lot / Code Info
Lot Numbers: 10916I2, 10917I2, 10918I2, 10919I2, 10920I2, 10921I2
Root Cause
Other
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