FDAFDA · Food and drugs·Recall number Z-0188-2020
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
Published October 30, 2019 · Recall initiated: September 26, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Life Technologies Holdings Pte Ltd
- Distributor
- states : AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, WA OUS: South Korea, ITALY, China, Japan, Singapore, Germany, TAIWAN, Poland
- Lot
- The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Singapore
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