Roche Recalls cobas EGFR Mutation Test V2 Due to False Negatives
Roche Molecular Systems is recalling cobas EGFR Mutation Test V2 kits because internal studies found they may produce false negative results when used with the cfDNA Sample Preparation kit.
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: The recall is classified as High because it involves a risk-of-harm product (medical diagnostic) where the hazard is a false negative result that could impact patient treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Roche Molecular Systems, Inc. is recalling the cobas EGFR Mutation Test V2. This medical device is a real-time PCR test used to detect specific mutations in the EGFR gene for non-small cell lung cancer patients. The recall involves 735 EGFR devices and 509 cfDNA devices.
The recall was initiated after internal studies using contrived plasma specimens revealed that the test inconsistently generated "No Mutation Detected" (false negative) results for several mutations, including L8568R, Exon 19 deletion, and T790M, when utilized with the cobas cfDNA Sample Preparation kit. The affected lots are W08792, W11783, W11438, W14903, W05108, W11435, and W12238.
The products were distributed in various foreign countries, including Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, and the United Kingdom. Healthcare providers and laboratories should stop using the affected test kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons
- Manufacturer
- Roche Molecular Systems, Inc.
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 (6)
- Lot W08792
- Lot W11783
- Lot W11438
- Lot W14903
- Lot W05108. Lot W11435
- Lot W12238
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Roche Molecular Systems, Inc.
See all →- HighRoche cobas Influenza Test Recall Due to False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche Influenza A/B and RSV Test Kit Recalled for False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche cobas Flu/COVID assay recalled for false negative influenza results
FDA (Devices) · 2023-02-15
- HighMedical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
FDA (Devices) · 2022-10-26
- ModerateCobas Liat respiratory virus analyzer units recalled for false Influenza B results
FDA (Devices) · 2022-04-06
Same hazard · false negative result
See all →- HighBioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results
FDA (Devices) · 2026-08-19
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighLuminex VERIGENE Gram Negative Blood Culture Test Recalled
FDA (Devices) · 2025-06-11
- HighVERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results
FDA (Devices) · 2023-07-05
- HighMedical device test system recalled for decreased reactivity and false-negative results
FDA (Devices) · 2022-12-07