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U.S. Department of Health and Human Services

Class 2 Device Recall Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

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 Class 2 Device Recall Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)see related information
Date Initiated by FirmMarch 20, 2026
Date PostedApril 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1927-2026
Recall Event ID 98625
PMA NumberP170019 
Product Classification Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
ProductSequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Code Information Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
FEI Number 3010679023
Recalling Firm/
Manufacturer		 Foundation Medicine, Inc.
150 2nd St
Cambridge MA 02141-2115
For Additional Information ContactClarke Madigan
617-418-2200
Manufacturer Reason
for Recall		Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
FDA Determined
Cause 2		Under Investigation by firm
ActionFoundation 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 in Commerce163 units
DistributionUS Nationwide distribution in the states of Massachusetts and North Carolina.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = PQP
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