FoundationOne CDx Test Results
Reported: December 26, 2018 Initiated: October 31, 2018 #Z-0649-2019
Product Description
FoundationOne CDx Test Results
Reason for Recall
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
Details
- Recalling Firm
- Foundation Medicine, Inc.
- Units Affected
- 800 reports
- Distribution
- US nationwide
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
FoundationOne CDx Test Results. Recalled by Foundation Medicine, Inc.. Units affected: 800 reports.
Why was this product recalled? ▼
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0649-2019.
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