MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended t
Summary
The FDA issued a Class II for MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cance by CARIS LIFE SCIENCES. Reason: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation.
Details
Source
Device Recall
External ID
Z-2521-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF
Quantity Affected: 1
Reason for Recall
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Distribution
U.S. Nationwide distribution in the state of NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-17
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CARIS LIFE SCIENCES) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CARIS LIFE SCIENCES have FDA actions?
This is the only FDA action we have on record for CARIS LIFE SCIENCES in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2521-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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