- Recalling firm
- Foundation Medicine, Inc.
- Reason for recall
- Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
- Affected products (lot / model / serial)
- Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
- Units affected
- 163 units
- Distribution pattern
- US Nationwide distribution in the states of Massachusetts and North Carolina.
- Firm location
- Cambridge, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1927-2026
- Recall initiated
- March 20, 2026
- FDA classification date
- April 22, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98625
- Last updated on HTM Vibe
- July 24, 2026