Sequencing Agent SEQ0067 recall
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Why was Sequencing Agent SEQ0067 recalled?
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
- Product
- Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- Recalling firm
- Foundation Medicine, Inc.
- Quantity
- 163 units
- Distribution
- US Nationwide distribution in the states of Massachusetts and North Carolina.
- Recall date
- April 29, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)