Qiagen Recalls EGFR PCR Kits Due to False Positive Risk
Qiagen is recalling 530 therascreen EGFR RGQ PCR Kits because a fluorescence artifact can cause rare false mutation positive results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the risk occurs in 'rare cases' and does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Qiagen Sciences LLC is recalling 530 units of the therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121. The recall covers all lots of the product that are within their expiration date. The affected kits were distributed nationwide in the United States.
The recall is being issued because there is a risk of a false mutation positive result in rare cases. This error can occur due to a fluorescence artifact in the mutation assay. In these instances, the test controls pass correctly, but the artifact leads to an incorrect valid mutation positive result.
Healthcare providers and laboratories should stop using the affected kits and contact Qiagen Sciences LLC for further instructions on how to return or dispose of the product.
The recalled product
- Product
- therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
- Manufacturer
- Qiagen Sciences LLC
- Hazard
- Affected units
- 530
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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