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.
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: Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia. Quantity: 4 units Lot/code info: ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 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.