FDA-Device2019-10-30Class II
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
Life Technologies Holdings Pte Ltd
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
Sold states
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
Affected count
total of Ion+vela +chassis =400 units
Manufactured in
Blk 33 Marsiling Ind Estate Road 3, #07-06, Singapore, Singapore
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0187-2020Don't want to check this manually?
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