Home / Recalls / Medical Devices
Life Technologies Holdings Pte Ltd recalls Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20
Recalled October 30, 2019 · FDA recall Z-0187-2020 · Life Technologies Holdings Pte
Hazard
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 · FDA Class II
Units
total of Ion+vela +chassis =400 units
Sold at
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
Description
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
Product
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
Manufacturer(s)
Life Technologies Holdings Pte Ltd
Made in
Singapore
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →