Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 Recalled by Life Technologies Holdings Pte Ltd Due to Torrent SuiteTM Dx analysis software, a component of...

Date: September 26, 2019
Company: Life Technologies Holdings Pte Ltd
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Life Technologies Holdings Pte Ltd directly.

Affected Products

Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9

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

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 17 states: AZ, CA, CO, CT, FL, GA, IN, MD, MA, NJ, NM, NY, NC, OR, TX, VA, WA

Affected (17 states)Not affected

About Life Technologies Holdings Pte Ltd

Life Technologies Holdings Pte Ltd has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report