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Life Technologies Holdings Pte Recalls

4 recalls on record · October 30, 2019 to October 30, 2019 · Medical Devices

October 30, 2019Medical DevicesFDA
Life Technologies Holdings Pte Ltd recalls Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 S
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
October 30, 2019Medical DevicesFDA
Life Technologies Holdings Pte Ltd recalls Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20
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
October 30, 2019Medical DevicesFDA
Life Technologies Holdings Pte Ltd recalls Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v
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
October 30, 2019Medical DevicesFDA
Life Technologies Holdings Pte Ltd recalls Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v
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
Life Technologies Holdings Pte Recalls | RecallWatchUSA