FoundationOne CDx Test Results
FDA device recall Z-0649-2019 · posted 2018-12-20 · Terminated
Recall details
- Recalling firm
- Foundation Medicine, Inc.
- Reason for recall
- An incorrect test result for a single analyte may have been reported for up to 800 physician reports
- Action taken
- On October 31, 2108, an outreach program was implemented by Foundation Medicine's Medical Affairs team to advise ordering physicians who received reports of possibility that the relevant reports could contain an incorrect test result.
- Root cause
- Other
- Status
- Terminated
- Product code
- PQP
- Quantity affected
- 800 reports
- Distribution
- US nationwide
- Date initiated
- 2018-10-31
- Date posted
- 2018-12-20
- Date terminated
- 2020-04-17
- Location
- Cambridge, MA
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