Siemens Atellica CH Enzymatic Creatinine Recalled for Acetaminophen Interference
Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with 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 the hazard involves potential interference in diagnostic assays which could lead to incorrect medical decisions, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,488 units of Atellica CH Enzymatic Creatinine reagents (Material Number 11097533). The product is used for the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
The recall is due to the presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, which may cause interference in certain chemistry assays when testing patient samples. This interference could potentially affect the accuracy of the diagnostic results.
The affected lots are 100051, 100025, 100002, 190294, 190256, 190200, 190171, 190135, 190126, 100087, 100109, 100136, 100167, and 110032. The products were distributed worldwide and nationwide in the United States. Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,488
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 (8)
- Lot #s 100051
- 100025
- 100002
- 190294
- 190256
- 190200
- 190171
- 190135
Distribution
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- 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
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · test interference
See all →- HighSiemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results
FDA (Devices) · 2024-04-24
- HighFetal Membrane Rupture Test Kits Recalled for False Positive Results
FDA (Devices) · 2024-04-24
- HighAbbott Alinity i Anti-HCV Reagent Kit Recall for Falsely Elevated Test Results
FDA (Devices) · 2024-04-10
- HighHepatitis B Diagnostic Test Kits Recalled for Test Interference
FDA (Devices) · 2023-03-01
- HighFDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination
FDA (Devices) · 2022-06-15