Life Technologies Holdings Pte Ltd
FDA Regulatory Profile
Life Technologies Holdings Pte Ltd has 5 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-0211-2027 · Class II · Aug 14, 2026
- Latest inspection
- Dec 15, 2022 · NAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 5 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0211-2027 | Class II | Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx… | Aug 14, 2026 |
| Z-0185-2020 | Class II | Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa… | Sep 26, 2019 |
| Z-0186-2020 | Class II | Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa… | Sep 26, 2019 |
| Z-0188-2020 | Class II | Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software… | Sep 26, 2019 |
| Z-0187-2020 | Class II | Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ… | Sep 26, 2019 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Dec 15, 2022 | Singapore, Singapore | Devices | No Action Indicated (NAI) | 3003673482 |
| Dec 3, 2015 | Singapore, Singapore | Devices | Voluntary Action Indicated (VAI) | 3003673482 |
| Jul 9, 2014 | Singapore, Singapore | Devices | No Action Indicated (NAI) | 3003673482 |
| Aug 22, 2013 | Singapore, Singapore | Devices | Voluntary Action Indicated (VAI) | 3003673482 |
| Nov 29, 2012 | Singapore, Singapore | Devices | No Action Indicated (NAI) | 3003673482 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003673482 | Singapore, Singapore | 5 | Dec 15, 2022 |