ADVIA Chemistry urinary protein reagent quality control failure
Siemens Healthcare is recalling ADVIA Chemistry urinary protein test reagents due to potential quality control issues that could produce inaccurate patient 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: FDA Class II medical device with quality control issues affecting diagnostic accuracy. No illnesses or injuries reported in the source text, making this a risk-of-harm product where potential injury has not yet been reported, which places it at score 3 per the rubric.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) test reagents, specifically lot 140. The recall also affects Atellica CH UCFP lot 130414. These are laboratory test reagents used in clinical settings to measure protein levels in urine and cerebrospinal fluid samples.
The recall is due to potential quality control failures that could result in biased or inaccurate test results. If test results are inaccurate, patients could receive incorrect diagnoses or treatment decisions based on these flawed results.
A total of 143 units have been distributed worldwide, including 17 units in the United States distributed across 15 states and Puerto Rico. International distribution includes Australia, Austria, Canada, and many other countries.
Healthcare facilities and laboratories that have received these reagent lots should stop using them and contact Siemens Healthcare Diagnostics for instructions on replacement product and verification of affected test results.
The recalled product
- Product
- ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (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 (3)
- Siemens Material Number: 11319151
- UDI-DI: 00630414279176
- Lot number: 140
Distribution
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 →- 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
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
- 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
Same hazard · quality control failure
See all →- High5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- HighEXENT Analyser marked plates as passed without performing quality control
FDA (Devices) · 2026-06-17
- HighPreeclampsia growth factor assay recalled over out-of-range quality control values
FDA (Devices) · 2026-04-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- ModerateHeparin control material recalled after quality control results fell below acceptance range
FDA (Devices) · 2025-08-20