Roche recalls cobas EGFR Mutation Test v2 due to false mutation results for Ex20Ins mutations, potentially leading to incorrect cancer treatment decisions. Affected units include all lot numbers of the system.
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Roche is recalling its cobas EGFR Mutation Test v2 system because it can produce false results for Ex20Ins mutations, which might lead to incorrect cancer treatments. This affects all units of the system sold with the catalog number 07248563190.
The test can show false positive results for Ex20Ins mutations, which are specific genetic changes in lung cancer. This could lead to unnecessary treatments or missed treatments if the results are used to guide therapy.
Patients undergoing cancer treatment who use this test may be at risk of incorrect treatment decisions. Healthcare providers using the system for testing are most affected.
Check for the cobas EGFR Mutation Test v2 system with catalog number 07248563190. All lot numbers are affected by this recall.
Identify the catalog number 07248563190 on the system to confirm if it is affected.
The recall is due to potential false results, which could lead to incorrect cancer treatments, but the test itself is not inherently dangerous.
Check the catalog number 07248563190 to confirm if it is affected; all lot numbers are included in the recall.
The recall does not specify a stop-use instruction, so you may continue using it but should verify the catalog number.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0083-2022 — Roche Roche Hello, I own a Roche that is covered by recall Z-0083-2022 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
