Z-1747-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- April 9, 2025
- Termination Date
- N/A
- 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.