FDA Medical devices recall ·
FoundationOne Companion Diagnostic (F1CDx) recall
- Recall number
- Z-1747-2025
- Date
- (initiated April 9, 2025)
- Company / brand
- Foundation Medicine, Inc.
150 2nd St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FoundationOne Companion Diagnostic (F1CDx)
Why was it recalled?
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
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
ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.
Distribution
Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
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-1747-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.