Z-0188-2020 Class II Terminated
FDA device recall Z-0188-2020 was initiated by Life Technologies Holdings Pte Ltd on September 26, 2019 and is designated Class II. Reason for recall: 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 loc… The recall status is terminated (terminated November 23, 2021). Affected quantity: total of Ion+vela +chassis =400 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- September 26, 2019
- Termination Date
- November 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- total of Ion+vela +chassis =400 units
Product Description
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
Reason for Recall
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
Distribution Pattern
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
Code Information
The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type