Roche Recalls cobas EGFR Mutation Test Kits Due to False Positives
Roche Molecular Systems is recalling 190 kits of the cobas EGFR Mutation Test because they may produce false positive results for Exon 20 insertion mutations.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 III, which is defined as unlikely to cause adverse health consequences. The hazard is a diagnostic error (false positive) rather than a direct physical injury or contamination.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 190 kits of the cobas EGFR Mutation Test, an epidermal growth factor receptor (EGFR) gene DNA assay. The recall is limited to kit batch T08661.
The recall was initiated because the affected kits are detecting false positive results for Exon 20 insertion mutations. This issue may lead to inaccurate diagnostic information for patients.
The distribution pattern for this recall is listed as Foreign. Healthcare providers and laboratories should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 190
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)
- T08661
Distribution
Distribution scope not specified by the agency.
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