FDA (Devices) recall action 83786
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.
Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.
Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for specific clinical variants.
Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.