Device product
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
Z-0188-2020
Product summary
- Event
- Event 83786
- Status
- Terminated
- Classification
- Class II
- Quantity
- total of Ion+vela +chassis =400 units
- Official record key
device-enforcement:Z-0188-2020
Official wording
Reason: 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
Code information: The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type
Distribution pattern: states : AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, WA OUS: South Korea, ITALY, China, Japan, Singapore, Germany, TAIWAN, Poland
Derived failure modes
-
Unknown
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