Z-1927-2026 Class II Ongoing
FDA device recall Z-1927-2026 was initiated by Foundation Medicine, Inc. on Mar 20, 2026 and is designated Class II. Reason for recall: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants The recall status is ongoing. Affected quantity: 163 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 29, 2026
- Initiation Date
- Mar 20, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163 units
Product Description
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Reason for Recall
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Distribution Pattern
US Nationwide distribution in the states of Massachusetts and North Carolina.
Code Information
Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1927-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026