Recall Z-2290-2020— Qiagen Sciences LLC
Class II · Terminated
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2020-04-08, terminated 2021-06-03. FDA's recall record names no specific 510(k) clearance for this event. Product: therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121. Reason: 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..
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-08
- Terminated
- 2021-06-03
- Firm location
- Germantown, MD, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.