Foundation Medicine, Inc.: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Recalling firm
- Foundation Medicine, Inc.
- Product
- Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- Reason
- Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of Massachusetts and North Carolina.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e8336713-b73d-4103-9016-764878fb234b