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 16, 2007).
- Company
- Abbott Laboratories
- Recall Initiated
- May 12, 2004
- Posted
- March 16, 2007
- Terminated
- May 1, 2007
- Recall Number
- Z-0639-2007
- Quantity
- 6,893 units
- Firm Location
- Santa Clara, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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).
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.
Lot / Code Info
Lot Numbers: 14454I2, 14455I2, 14456I2, 14457I2, 15611I2
Root Cause
Other
Action Taken
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.