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-product 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
Recall Letter-On 2/24/04, the firm initiated the recall and its notification explaining the reason for the recall and requesting the product be destroyed
Affected by this recall?
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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: 10916I2, 10917I2, 10918I2, 10919I2, 10920I2, 10921I2
Units Affected
9,800 units