therascreen EGFR RGQ PCR Kit recall
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Why was therascreen EGFR RGQ PCR Kit 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots
- Product
- therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
- Recalling firm
- Qiagen Sciences LLC
- Quantity
- 530 kits within expiry
- Distribution
- US Nationwide.
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)