Qiagen Sciences LLC: Medical Device Recall in 2020 - (Recall #: Z-2290-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 8, 2020

Date Posted: June 17, 2020

Recall Number: Z-2290-2020

Event ID: 85565

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.

Status: Terminated

Product Quantity: 530 kits within expiry

Code Information:

All lots

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated