Life Technologies recalls Torrent Suite Dx Software version 5.4 (Catalog A31774) due to incorrect positive results when different variants are detected at the same genetic locus.
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
Life Technologies recalls Torrent Suite Dx Software version 5.4 (Catalog A31774) because it can show a positive result when a different genetic variant is detected at the same location as a clinical variant. This could lead to inaccurate test results for genetic analysis.
The software incorrectly displays a positive result when a different analytical variant is detected at the same genetic locus as a specified clinical variant. This can cause false positive results in genetic testing, potentially leading to incorrect diagnoses or treatment decisions.
Users of the Torrent Suite Dx software with the Ion PGM Dx Instrument System are affected. Laboratory technicians and genetic testing professionals are most at risk due to potential for inaccurate results.
Check for Torrent Suite Dx Software version 5.4 (Catalog Number A31774) with the Sentosa SQ Suite Software label. This software is used with the Ion PGM Dx instrument system.
Install the latest version of Torrent Suite Dx Software (v5.6.15 or newer) to correct the issue.
The software incorrectly displays a positive result when a different analytical variant is detected at the same genetic locus as a specified clinical variant, which can cause false positive results.
Check for Torrent Suite Dx Software version 5.4 (Catalog Number A31774) with the Sentosa SQ Suite Software label installed on your Ion PGM Dx instrument system.
No, the hazard is limited to potential false positive results in genetic testing, not physical harm.
We’ve drafted a message you can send Life Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-0186-2020 — Life Technologies Life Technologies Hello, I own a Life Technologies that is covered by recall Z-0186-2020 from Life Technologies. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
