FDAFDA · Food and drugs·Recall number Z-2290-2020
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Published June 17, 2020 · Recall initiated: April 8, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Qiagen Sciences LLC
- Distributor
- US Nationwide.
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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