FDASeptember 26, 2019device

Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

life technologies holdings ptelifelife technologies

UPCs

10190302005654

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178 — Recall Details · AllClear