CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
- Company
- Abbott Laboratories
- Recall Initiated
- September 29, 2004
- Posted
- April 3, 2007
- Terminated
- May 1, 2007
- Recall Number
- Z-0706-2007
- Quantity
- 27,411 units
- Firm Location
- Santa Clara, CA
Reason for Recall
Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range
Distribution
Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republic, Germany, Hong Kong, Japan, Korea, New Zealand, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad & Tobago, Uruguay, and Venezuela.
Lot / Code Info
Lot Numbers: 14465I2, 15597I2, 15598I2, 16752I2, 16753I2, 16754I2, 17943I2, 17946I2, 17947I2, 17949I2, 17950I2, 17952I2, 17953I2, 17954I2, 18107I2, 18108I2, 18109I2, 18110I2
Root Cause
Other
Action Taken
On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.