Life Technologies recalls Torrent Suite Dx Software v5.6.4 due to incorrect positive results when detecting certain genetic variants. Affected users should contact for remedy.
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 is recalling Torrent Suite Dx Software version 5.6.4 because it can show a positive result when a different variant is detected at the same genetic location as a clinical variant. This could lead to inaccurate test results.
The software incorrectly displays a positive result when a different analytical variant is detected at the same genetic location as a specified clinical variant. This can cause inaccurate genetic testing results.
Users of the Torrent Suite Dx software with version 5.6.4 or Sentosa SQ Suite Software v5.6.20 are affected. Laboratory technicians and genetic testing professionals are most at risk.
Check for software version 5.6.4 or Sentosa SQ Suite Software v5.6.20. The software is used with the Ion PGM Dx instrument system.
Verify your software version by checking the catalog number or version number in the software settings.
The software may cause inaccurate test results but does not pose a direct safety risk.
Check for software version 5.6.4 or Sentosa SQ Suite Software v5.6.20 on the Ion PGM Dx instrument system.
The recall record does not specify a remedy, so contact Life Technologies for assistance.
We’ve drafted a message you can send Life Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-0187-2020 — Life Technologies Life Technologies Hello, I own a Life Technologies that is covered by recall Z-0187-2020 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.
