FDA Device

CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

Hazard

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).

What You Should Do

Remedy

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.

Products

CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Brand
Abbott Laboratories
UPC
Lot Numbers:  14454I2, 14455I2,  14456I2,  14457I2,  15611I2

Units Affected

6,893 units