Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant

1. Notify all PGM Dx users in your facility of this issue. 2. Require that the Test_Report.pdf file be used for reporting results for all future sample tests. 3. Require that the Test_Report.pdf file be used to confirm ALL positive call results. For sample result reporting that use the Test_Report.pdf file and NOT the Target_Summary.tab file, the results are valid, and no further action is needed. For sample result reporting that use the Target_Summary.tab file on the Torrent SuiteTM Dx software versions indicated above, customers MUST review ALL results obtained using the Target_Summary.tab file against the results shown in the Test_Report.pdf file to identify any occurrences of possible false positive reporting. 4. If you have shared reports using results from the Target_Summary.tab file, outside of your facility, you MUST notify those customers or facilities to take the required action. 5. Please complete the following Customer Response Sheet and submit sheet, along with this letter, by emailing a scanned copy to [email protected]. If you have any technical questions or concerns, please contact Technical Support at 800-955-6288 option 4 or [email protected]