# FDA recall Z-0187-2020

> **Life Technologies Holdings Pte Ltd** · Class II · device recall initiated 2019-09-26.

## Product

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

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

- **Recall number:** Z-0187-2020
- **Recalling firm:** Life Technologies Holdings Pte Ltd
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0187-2020

## Citation

> AI Analytics. FDA recall Z-0187-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0187-2020. Source: US FDA. Licensed CC0.

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