780 units. Class III Abbott Cell-Dyn 3000 Series 1

Abbott Cell-Dyn 3000 Series Hematology Systems, Cell-Dyn Reticulocyte Reagent, when used in combination with Cell-Dyn 3500 reticulocyte software enables a whole blood specimen to be analyzed for reticulocytes. The Reticulocyte Reagent is intended for in vitro diagnostic use (outside the body).

Recall #Z-715-9.

REASON

These lots may exhibit elevated Reticulocyte results. In some cases, the results may exceed the normal
range on normal specimens without a Reticulocyte data flag being observed.

CODE

Lot numbers: 4249512, 424812, 4362312, 4362412, 4362512, 4368312, 4368412, 4484012, 4491712,
4597912, 4598012, 4599712, 459912, 4617712, 4617912, 4729312, 4729512, 4842912.

MANUFACTURER
Abbott Laboratories, Santa Clara, California.

RECALLED BY

Manufacturer, by letter on February 25, 1999. Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

1,780 kits were distributed.