Life Technologies recalls Torrent Suite Dx software version 5.8 (catalogs A36601/A36602) due to incorrect positive results when different variants are detected at the same genetic locus. Affected users should contact for updates.
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 5.8 (catalog numbers A36601 and A36602) 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 incorrect test results.
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 test results for genetic conditions.
Users of the Torrent Suite Dx software for the Ion PGM Dx Instrument System. Those testing genetic variants are most at risk of incorrect results.
Check for software version 5.8 with catalog numbers A36601 or A36602 on the Ion PGM Dx Instrument System. The software is labeled as Torrent Suite Dx T430.
Reach out to Life Technologies for guidance on software updates or replacements.
The software may cause incorrect positive results but does not pose a direct safety risk to users.
Check for software version 5.8 with catalog numbers A36601 or A36602 on the Ion PGM Dx Instrument System.
Contact Life Technologies for guidance on software updates or replacements.
We’ve drafted a message you can send Life Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-0188-2020 — Life Technologies Life Technologies Hello, I own a Life Technologies that is covered by recall Z-0188-2020 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.
