FDA Medical Device Recalls (openFDA)
Foundation Medicine, Inc.: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- Recall number
- Z-1927-2026
- Recalling firm
- Foundation Medicine, Inc.
- Product
- Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- Status
- Open, Classified
- Initiated
- 2026-03-20
- Posted
- 2026-04-22
- Terminated
- not on file
- Reason
- Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
- Root cause
- Under Investigation by firm
- Action
- Foundation Medicine notified consignees via emailed letter on about 03/20/2026. Consignees were instructed to review, complete, sign and return the provided business reply form and review inventory and identify affected units, quarantine those units, and return to the FMI Boston Warehouse quarantine location via standard laboratory transfer practices. Consignees were also instructed to forward the notification to anyone within the facility that should be informed and if there is any impact that requires this notice to be forwarded to another facility, including facilities where units of inventory may have been transferred, contact that facility and provide them with this letter. Consignees were asked to retain the letter with laboratory records made aware that Foundation Medicine will work with the supplier of these components to replace impacted units.
- Quantity
- 163 units
- Distribution
- US Nationwide distribution in the states of Massachusetts and North Carolina.
- Lot, serial or model codes
- Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
- 510(k) numbers
- not on file
- PMA numbers
- ["P170019"]
- Product code
- PQP
- Firm FEI
- 3010679023
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28