Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System（PQP）

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants

Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

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.

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.

Distributed sample collection kit with an unapproved instruction for use.

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.

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

Extended Expiration Date prior to clearance

Extended Expiration Date prior to clearance

Extended Expiration Date prior to clearance

Extended Expiration Date prior to clearance

Identified potential false positive MSI-H on the test reports provided to the physicians.

An incorrect test result for a single analyte may have been reported for up to 800 physician reports

The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.

The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens.