Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0185-2020 — Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9

U.S. FDA — Device Enforcement · Singapore · 2019-09-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0185-2020
Date of alert
2019-09-26
Country / jurisdiction
Singapore
Risk level
Class II
Risk type
recall
Brand
Life Technologies Holdings Pte Ltd
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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