Class II recall Z-3335-2026: Siemens Healthcare Diagnostics, Inc.
Class II recall Z-3335-2026: Siemens Healthcare Diagnostics, Inc. (New York): Siemens Healthcare Diagnostics, Inc. Dated 28 days ago, it is in the active follow-up window. Score 62/100. 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: 6 related NY FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3335-2026 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223; |
| Reason | The potential for falsely elevated results. |
| Quantity | 42940 units (3938 US, 39002 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, |
| Recall initiated | 2026-08-17 |
| Reported | 2026-10-07 |
| Firm location | Tarrytown, NY, United States |
| Peer records CSV (7 NY records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- 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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Peer benchmark and outreach value: Class II recall Z-3335-2026: Siemens Healthcare Diagnostics, Inc. and 7 New York peers
- New York FDAPulse records like this one: 7
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every New York peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.
What is the FDAPulse record for Class II recall Z-3335-2026: Siemens Healthcare Diagnostics, Inc. in New York?
Class II device recall Z-3335-2026 by Siemens Healthcare Diagnostics, Inc.: The potential for falsely elevated results.
How does Class II recall Z-3335-2026: Siemens Healthcare Diagnostics, Inc. compare to other New York FDAPulse records?
It is 28 days old, still within a typical 45-day follow-up window.
Class II recall Z-3335-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3335-2026 | NY | 2026-10-07 |
| 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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