FDA recall Z-2290-2020

Product

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

Reason for recall

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.

Distribution

US Nationwide.

Key facts

Status

Terminated

Initiation date

2020-04-08

Report date

2020-06-17

Termination date

2021-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Germantown, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2290-2020