FDA Device recall Z-3335-2026
Atellica CH Revised C-Reactive Protein (RCRP)
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Atellica CH Revised C-Reactive Protein (RCRP) by Siemens Healthcare Diagnostics, citing the potential for falsely elevated results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3335-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-17 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Reason
The potential for falsely elevated results.
Identifiers
| code_info | Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Siemens Healthcare Diagnostics
- Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics - Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics - Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
FDA Device · Class III · 2026-08-12 · Siemens Healthcare Diagnostics - Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
FDA Device · Class II · 2026-08-12 · Siemens Healthcare Diagnostics - Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
FDA Device · Class III · 2026-08-12 · Siemens Healthcare Diagnostics
All Siemens Healthcare Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3335-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.