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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 3 Recall
Abbott Diagnostics CELL-DYN Diluent/Sheath Reagent		see related information
Date Posted March 01, 2007
Recall Number Z-0565-2007
Product CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
Code Information Lot Number 42063I2, List Number 01H73-01
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara, California 95054-1113
Reason for
Recall		 Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
Action Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.
Quantity in Commerce 652 (20 L. each) cubitainers
Distribution Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.
 
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