Singapore, Singapore
Life Technologies Holdings Pte Ltd recalls
1 recall recorded since 2018, most recently on 26 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 September 2019
- Terminated
- 23 November 2021
- Reason
- 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
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0188-2020, Z-0185-2020, Z-0186-2020, Z-0187-2020
- 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
- Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
- Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.