Torrent Suite Dx Software Version — Class II medical device recall Z-0185-2020
Terminated recall by Life Technologies Holdings Pte Ltd, reported 2019-10-30, distributed in AZ, CA, CO, CT, FL, GA, IN, MA…. Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a
| Recall number | Z-0185-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Life Technologies Holdings Pte Ltd, Singapore, Singapore |
| Recall initiated | 2019-09-26 |
| Classified | 2019-10-23 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2021-11-23 |
| Distributed | AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, WA |
| Countries outside the US | CN, DE, IT, JP, KR, PL, SG, TW |
| Quantity | 400 units |
| Reason classes | software |
| Model numbers | A29225OEM |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0185-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.