FDASeptember 26, 2019device

Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

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

10190302014090

Recall history

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

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