medical Class II Updated 2019-10-30

Life Technologies Holdings Pte Ltd recalls Torrent Suite Dx Software Version 5.6.4 Catalog Number:A331

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Affected States: AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, WA
Lot/Code Info: The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type
View official government recall

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