Recall Z-0186-2020— Life Technologies Holdings Pte Ltd
Class II · Terminated
Class II FDA medical device recall by Life Technologies Holdings Pte Ltd, initiated 2019-09-26, terminated 2021-11-23. It names one FDA 510(k) clearance: K170299. Product: Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15. 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.
- Recalling firm
- Life Technologies Holdings Pte Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-26
- Terminated
- 2021-11-23
- Firm location
- Singapore, Singapore
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.