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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97258

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 17, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CARIS LIFE SCIENCES

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.

Z-2521-2025
Recall number
Z-2521-2025
Initiated
June 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CARIS LIFE SCIENCES
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF

Distribution pattern

U.S. Nationwide distribution in the state of NY.