CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Hazard
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
What You Should Do
Remedy
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.
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Products
CELL-DYN 3200 Diluent/Sheath Reagent,
List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
- Brand
- Abbott Laboratories
- UPC
- Lot Numbers: 14465I2, 15597I2, 15598I2, 16752I2, 16753I2, 16754I2, 17943I2, 17946I2, 17947I2, 17949I2, 17950I2, 17952I2, 17953I2, 17954I2, 18107I2, 18108I2, 18109I2, 18110I2
Units Affected
27,411 units