Reported Jun 17, 2020 · Terminated
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Qiagen Sciences LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415
Is this the product you have?
therascreen EGFR RGQ PCR Kit (24)Reference Number REF 870121
- Lot codes and dates
- All lots
- Amount recalled
- 530 kits within expiry
Where it was sold
- 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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