Life Technologies Holdings Pte Ltd: Medical Device Recall in 2019 - (Recall #: Z-0186-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15

Product Classification:

Class II

Date Initiated: September 26, 2019

Date Posted: October 30, 2019

Recall Number: Z-0186-2020

Event ID: 83786

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

Status: Terminated

Product Quantity: total of Ion+vela +chassis =400 units

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

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

Voluntary or Mandated:

Voluntary: Firm initiated