FDA Device

Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01

Hazard

Product elicits fluorescent signal interference due to contamination.

What You Should Do

Remedy

On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

Products

Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01
Brand
Abbott Laboratories
UPC
Product Control/Lot # 9274912, (Exp. Date: 8/31/2003) Product Control/Lot # 9275012, (Exp. Date: 8/31/2003) Product Control/Lot # 9275212, (Exp. Date: 8/31/2003)

Units Affected

1383 units