Z-1747-2025 Class II Ongoing
FDA device recall Z-1747-2025 was initiated by Foundation Medicine, Inc. on Apr 9, 2025 and is designated Class II. Reason for recall: Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling… The recall status is ongoing. Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- Apr 9, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
FoundationOne Companion Diagnostic (F1CDx)
Reason for Recall
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
Code Information
ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 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-1747-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026