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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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