Biocartis recalls Idylla instruments with specific serial numbers due to false positive MSI-H test results. Affected units may give incorrect cancer detection results.
False-positive MSI-H results generated by the Idylla MSI Test.
Biocartis is recalling specific Idylla instruments that can produce false positive results for MSI-H cancer tests. This could lead to incorrect cancer diagnoses if used without the recall fix.
The Idylla instrument can generate false positive results for MSI-H (microsatellite instability-high) cancer tests. This means it might incorrectly indicate a patient has a certain type of cancer when they do not.
Patients using the Idylla instrument for cancer testing may be affected if they have the recalled serial numbers. Healthcare providers using these instruments for MSI-H testing are most at risk.
Check the serial numbers listed: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445. The instrument is labeled as an IVD (in vitro diagnostic) device for nucleic acid detection.
Verify your Idylla instrument's serial number against the list: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.
The Idylla instrument can produce false positive results for MSI-H cancer tests, which may lead to incorrect cancer diagnoses.
Check your serial number against the list provided. If it matches, contact Biocartis for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Biocartis to request your refund or repair — edit it as you like.
Subject: Recall Z-0836-2025 — Biocartis Biocartis Hello, I own a Biocartis that is covered by recall Z-0836-2025 from Biocartis. 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.
