Recall Z-0187-2020 ยท PFF High Throughput Dna Sequence Analyzer
Life Technologies Holdings Pte Ltd
Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
| Date | Sep 26, 2019 |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | 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.t |
| Quantity | total of Ion+vela +chassis =400 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170299 | Ion PGM Dx System Life Technologies Corporation, Jun 22, 2017 |