Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatogra…

Recall date

November 1, 2018

Source

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

Recall number

Z-0620-2019

FDA classification

Class II

Brand / firm

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Sold / distributed

IL, WV, NJ, AZ, MD, UT

Why it was recalled

lack of 510K

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

What was recalled

ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.