medical Class II Updated 2019-10-30

Life Technologies Holdings Pte Ltd recalls Torrent Suite Dx Software Version 5.8 Catalog Number:A36601

Recalled Product

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

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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