Home / Recalls / Life Technologies Holdings Pte Ltd / Z-0187-2020

Z-0187-2020 Class II Terminated

Recalled by Life Technologies Holdings Pte Ltd — Singapore

Recall Details

Product Type: Devices
Report Date: October 30, 2019
Initiation Date: September 26, 2019
Termination Date: November 23, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: total of Ion+vela +chassis =400 units

Product Description

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

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 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

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