Siemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
Siemens Healthcare Diagnostics is recalling Atellica CH Revised C-Reactive Protein reagent due to the potential for falsely elevated test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (falsely elevated diagnostic results) without reported injuries or illnesses, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Revised C-Reactive Protein (RCRP) reagent, identified by Siemens Material Number (SMN) 11537223. The recall affects 42,940 units distributed worldwide, including the United States and numerous international locations.
The recall was initiated due to the potential for falsely elevated results. This issue may affect the accuracy of C-Reactive Protein measurements performed using the affected reagent.
Healthcare facilities and laboratories should stop using the affected product and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- Product
- Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Siemens Material Number (SMN): 11537223
- UDI-DI: 00630414610887
- Lot numbers: All lots
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · false positive results
See all →- HighQuickVue Dipstick Strep A Test Recalled for False Positive Results
FDA (Devices) · 2026-05-20
- ModerateLeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results
FDA (Devices) · 2026-04-29
- ModerateLeadCare II Blood Lead Test Kit Recall for Inaccurate Results
FDA (Devices) · 2026-04-29
- HighLeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results
FDA (Devices) · 2026-04-29
- HighSolana Bordetella Complete Assay Kit Recalled for False Positive Results
FDA (Devices) · 2025-06-18
Similar recalls
- ModerateSiemens Atellica CH Revised C Reactive Protein Assay Software Flagging Issue
FDA (Devices) · 2025-04-16
- HighSiemens Atellica CH Protein Reagent Recalled for Carryover Affecting Test Results
FDA (Devices) · 2021-11-03
- ModerateSiemens Recalls Atellica CH High Sensitivity C-Reactive Protein Calibrator
FDA (Devices) · 2020-02-26
- HighAtellica hemoglobin A1c assay may return depressed patient results
FDA (Devices) · 2026-04-08
- HighSiemens Atellica CH diagnostic reagent carryover may cause false laboratory test results
FDA (Devices) · 2023-09-06
- HighSiemens Atellica CH Enzymatic Creatinine Reagent Recalled for Interference
FDA (Devices) · 2020-02-26