CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report
MI Cancer Seek recalled by Caris Life Sciences
Caris Life Sciences is recalling MI Cancer Seek, distributed nationwide in the US. The recall was initiated on 17 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2521-2025
- FDA event ID
- 97258
- Recalling firm
- Caris Life Sciences, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2025
- FDA classified
- 4 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Jun 2025 | Recall initiated by company | |
| 4 Sep 2025 | Classified by FDA | +79 days |
| 10 Sep 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution in the state of NY.
Questions about this recall
Why was it recalled?
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Which lots are affected?
Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF
Where was it sold?
U.S. Nationwide distribution in the state of NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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