FDA recall Z-0188-2020

Life Technologies Holdings Pte Ltd · Class II · 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

Reason for recall

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

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

Key facts

Status: Terminated
Initiation date: 2019-09-26
Report date: 2019-10-30
Termination date: 2021-11-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Singapore, Singapore

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0188-2020