therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Reported: June 17, 2020 Initiated: April 8, 2020 #Z-2290-2020
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.
Details
- Recalling Firm
- Qiagen Sciences LLC
- Units Affected
- 530 kits within expiry
- Distribution
- US Nationwide.
- Location
- Germantown, MD
Frequently Asked Questions
What product was recalled? ▼
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121. Recalled by Qiagen Sciences LLC. Units affected: 530 kits within expiry.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2290-2020.
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