The Recall Desk
HighFDA (Devices)·Z-0083-2022·Announced 2021-10-20

Cobas EGFR Mutation Test v2 may return false mutation detection results

The cobas EGFR Mutation Test v2 may produce false positive results for exon 20 insertion mutations, potentially leading to inappropriate treatment. Healthcare providers should verify detected mutations using alternative methods.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall for a diagnostic test that presents a risk-of-harm to patients through potential misdiagnosis. False test results could lead to inappropriate clinical treatment decisions, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The cobas EGFR Mutation Test v2, a molecular diagnostic system manufactured by Roche Molecular Systems, Inc. (Catalog Number 07248563190), has been recalled by the FDA due to a defect in test accuracy.

The system may produce false positive results when detecting the exon 20 insertion (Ex20Ins) mutation. These false results could lead to inappropriate treatment decisions, as healthcare decisions may be based on inaccurate genetic test information.

The recall affects 507 units distributed in the United States and 6,676 units distributed internationally across numerous countries including Canada, the UK, and European nations. All lot numbers of this product are included in the recall.

Healthcare providers and laboratory directors using this product should contact Roche Molecular Systems, Inc. for guidance. All exon 20 insertion mutations detected with this system should be verified using alternative testing methods before treatment decisions are made.

The recalled product

Product
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Manufacturer
Roche Molecular Systems, Inc.
Category
Medical Device
Hazard
  • false-mutation-detection
  • diagnostic-error
  • treatment-risk

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 lot numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category