Abbott Laboratories recalls CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro…

Recall date

February 20, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1074-2019

FDA classification

Class II

Brand / firm

Abbott Laboratories

Sold / distributed

Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Co…

Why it was recalled

There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.