Clinical Diagnostic Solutions, Inc. recalls Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

Recall date

January 2, 2020

Source

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

Recall number

Z-1001-2020

FDA classification

Class II

Brand / firm

Clinical Diagnostic Solutions, Inc.

Sold / distributed

Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.

Why it was recalled

A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.

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

What was recalled

Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011