Z-0185-2020 Class II Terminated
FDA device recall Z-0185-2020 was initiated by Life Technologies Holdings Pte Ltd on Sep 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… The recall status is terminated (terminated Nov 23, 2021). Affected quantity: total of Ion+vela +chassis =400 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2019
- Initiation Date
- Sep 26, 2019
- Termination Date
- Nov 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- total of Ion+vela +chassis =400 units
Product Description
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0185-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026