Summary
The FDA issued a Class II for FoundationOne Companion Diagnostic (F1CDx) by Foundation Medicine, Inc.. Reason: Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx c.
Details
Source
Device Recall
External ID
Z-1747-2025
Action Date
2025-05-21
Status
Ongoing
Category
device
Product Description
FoundationOne Companion Diagnostic (F1CDx)
Lot/Code Info: ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.
Quantity Affected: 4 units
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-09
Company
Cambridge, MA
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 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Foundation Medicine, Inc. has 7 FDA actions in our database, including 7 recalls.
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 (Foundation Medicine, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Foundation Medicine, Inc. have FDA actions?
Foundation Medicine, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1747-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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