Z-1891-2025 Class II Ongoing
FDA device recall Z-1891-2025 was initiated by Foundation Medicine, Inc. on Feb 15, 2023 and is designated Class II. Reason for recall: An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 11, 2025
- Initiation Date
- Feb 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
FoundationOne Companion Diagnostic (F1CDx)
Reason for Recall
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Distribution Pattern
US Nationwide distribution in the state of WI.
Code Information
Report Number: ORD-XXXXX04-01; Note: The above characters have been redacted to minimize patient information disclosure.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1891-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026