Caris Life Sciences recalls MI Cancer Seek REF MSC000 due to potential incorrect drug therapy recommendations from test results. Affected units have specific UDI codes. Contact for remedy.
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Caris Life Sciences is recalling its MI Cancer Seek REF MSC000 cancer test kit because it may provide incorrect results that lead to wrong drug therapy recommendations. This could affect cancer treatment decisions if used without proper verification.
The test may give incorrect results that could lead to inappropriate drug therapy recommendations. This happens because the test is designed to provide tumor mutational profiling but has a potential error in its results interpretation.
Healthcare professionals using the MI Cancer Seek test kit for cancer patients with solid tumors. Those who rely on the test results for treatment decisions are most at risk.
Check for the UDI code (01)00860008613325(21)H5HJHDSXF on the product label. The product is a single-site assay for cancer patients with solid tumors.
Look for the UDI code (01)00860008613325(21)H5HJHDSXF on the test kit label.
The product is MI Cancer Seek REF MSC000 with UDI code (01)00860008613325(21)H5HJHDSXF.
The test may provide incorrect results that could lead to wrong drug therapy recommendations for cancer patients.
The recall record does not specify a remedy.
We’ve drafted a message you can send Caris Life Sciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2521-2025 — Caris Life Sciences Caris Life Sciences Hello, I own a Caris Life Sciences that is covered by recall Z-2521-2025 from Caris Life Sciences. 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.
