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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Diagnostic Equipment

MI Cancer Seek Assay Recalled for Incorrect Drug Therapy Recommendations

Agency Publication Date: September 4, 2025
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Summary

Caris Life Sciences has recalled one unit of its MI Cancer Seek assay because it provided an incorrect test result, leading to a wrong drug therapy recommendation. The MI Cancer Seek is a laboratory test used by doctors to analyze cancer tumors and determine the most effective treatment for patients. While only one unit is affected, this specific error could result in a patient receiving an ineffective or harmful medication based on flawed genetic data. Laboratory professionals should contact the manufacturer immediately to return or correct the device.

Risk

Incorrect test results from this assay can cause doctors to prescribe the wrong cancer treatment, potentially leading to treatment failure or unnecessary side effects. One instance of an incorrect drug therapy recommendation has already occurred.

What You Should Do

  1. This recall affects one unit of the MI Cancer Seek assay (Catalog Number MSC000) with UDI code 0100860008613325 and Serial Number H5HJHDSXF.
  2. Stop using the recalled product.
  3. Contact Caris Life Sciences or your distributor to arrange for the return, replacement, or correction of the device.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MI Cancer Seek
Model / REF:
MSC000
Serial Numbers:
H5HJHDSXF
UDI:
00860008613325

Single-site assay for tumor mutational profiling.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97258
Status: Active
Manufacturer: CARIS LIFE SCIENCES
Sold By: Caris Life Sciences
Manufactured In: United States
Units Affected: 1
Distributed To: New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.