FDA Medical devices recall ·
FoundationOne Companion Diagnostic (F1CDx) recall
- Recall number
- Z-1891-2025
- Date
- (initiated February 15, 2023)
- Company / brand
- Foundation Medicine, Inc.
150 2nd St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FoundationOne Companion Diagnostic (F1CDx)
Why was it recalled?
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Report Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.
Distribution
US Nationwide distribution in the state of WI.
States: Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1891-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.