Class II recall Z-0211-2027: Life Technologies Holdings Pte Ltd
Class II recall Z-0211-2027: Life Technologies Holdings Pte Ltd: Life Technologies Holdings Pte Ltd. Dated 7 days ago, it is inside the fresh trigger window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 499 related FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0211-2027 |
| Recalling firm | Life Technologies Holdings Pte Ltd |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer |
| Reason | DNA or RNA sequencing system software has vulnerabilities. |
| Quantity | 16 |
| Distribution | US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK. |
| Recall initiated | 2026-08-14 |
| Reported | 2026-10-28 |
| Firm location | Singapore, Singapore |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 7 days ago.
What is the FDAPulse record for Class II recall Z-0211-2027: Life Technologies Holdings Pte Ltd?
Class II device recall Z-0211-2027 by Life Technologies Holdings Pte Ltd: DNA or RNA sequencing system software has vulnerabilities.
How does Class II recall Z-0211-2027: Life Technologies Holdings Pte Ltd compare to other FDAPulse records?
It is fresh: dated 7 days ago, inside the window where early outreach matters most.
Class II recall Z-0211-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0211-2027 | 2026-10-28 | |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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