Reported Dec 4, 2019 · Terminated
FoundationOne CDx test report
Foundation Medicine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Foundation Medicine, Inc. · 150 2nd St · Cambridge, MA · 02141-2115
Is this the product you have?
- FoundationOne CDx test report
- Lot codes and dates
- Model/Lot/Serial Number
QRF150009.01QRF150228.01QRF150108.01QRF149795.01QRF150117.01QRF150247.01QRF149634.01QRF128938.01
- Model/Lot/Serial Number
- Amount recalled
- 8 reports
Where it was sold
Why it was recalled
Identified potential false positive MSI-H on the test reports provided to the physicians.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Foundation Medicine, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.