Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Reason for recall: Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports. Distribution: US Nationwide distribution in the state of MI. Quantity: 2 units Lot/code info: Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.