Qiagen Sciences LLC recalls therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

Recall date

April 8, 2020

Source

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

Recall number

Z-2290-2020

FDA classification

Class II

Brand / firm

Qiagen Sciences LLC

Sold / distributed

US Nationwide.

Why it was recalled

There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.

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

What was recalled

therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121