Siemens Advia Chemistry Urinary Protein Reagent Recall for Inaccurate Test Results
Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a risk-of-harm medical device where injury has not yet been reported. While classified as FDA Class II, the recall involves potential for inaccurate diagnostic test results that could affect treatment decisions, but no actual patient harm or hospitalizations are documented.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) reagent. The recall affects all lots of this diagnostic reagent.
The firm has confirmed a potential for reagent carryover that can impact Enzymatic Hemoglobin A1c test results. Specifically, the carryover can cause Hemoglobin A1c results to be falsely depressed (lower than they should be). Falsely low A1c results may affect the consideration of appropriate patient intervention or treatment decisions.
This reagent is used in clinical laboratories that operate Advia Chemistry analyzers. Affected units are distributed worldwide, including 246 units in the United States and 689 units outside the United States.
Healthcare facilities using this reagent should contact Siemens Healthcare Diagnostics for guidance on this recall. Laboratories should review any A1c results obtained with affected reagent lots and consider whether repeat testing may be warranted for patient management decisions.
The recalled product
- Product
- Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (1)
- All lots impacted
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- 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 · reagent carryover
See all →- ModerateSiemens Atellica CH Total Protein II Recalled for Reagent Carryover
FDA (Devices) · 2023-09-06
- HighSiemens Atellica CH diagnostic reagent carryover may cause false laboratory test results
FDA (Devices) · 2023-09-06
- HighLaboratory diagnostic test may produce inaccurate results from reagent carryover
FDA (Devices) · 2023-09-06
- HighSiemens Atellica CH LDL Cholesterol analyzer reagent carryover issue
FDA (Devices) · 2023-09-06
- HighAtellica CH Triglycerides_2 Reagent Recalled Due to Magnesium Test Interference
FDA (Devices) · 2023-09-06
Similar recalls
- HighADVIA Chemistry Urinary Protein Reagent Carryover Causing Incorrect Creatinine Results
FDA (Devices) · 2023-08-30
- HighADVIA Chemistry urinary protein reagent quality control failure
FDA (Devices) · 2024-09-18
- HighSiemens ADVIA Chemistry Hemoglobin A1c Reagent Kits Recalled for Bias
FDA (Devices) · 2015-12-02
- SevereSiemens ADVIA Chemistry Lipase Reagent Recalled for Carryover Contamination
FDA (Devices) · 2015-04-29
- ModerateSiemens Uric Acid Assay Recalled Due to Interference
FDA (Devices) · 2016-05-18
- HighSiemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues
FDA (Devices) · 2022-04-20