healthClass IIRecalled on Sep 10, 2025

MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational pro

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Sold At: CARIS LIFE SCIENCES(U.S. Nationwide distribution in the state of NY.)

Recall #: FDA-DEVICE-Z-2521-2025

Source: FDA-ENFORCEMENT

MI Cancer Seek REF MSC000  UDI Code: (01)00860008613325(21)H5HJHDSXF    MI Cancer Seek is a single-site assay intended to provide tumor mutational pro

Product Identification

Lot/Batch Codes:
Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF

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Summary

Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

What to do next

  • 1Stop using this product - may cause temporary or medically reversible health problems
  • 2Check with retailer or manufacturer for recall status and remedy options
  • 3Contact CARIS LIFE SCIENCES for return or refund information
  • 4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.