Siemens ADVIA Chemistry Fructosamine Reagent Recalled for Potential Interference
Siemens is recalling ADVIA Chemistry Fructosamine Reagent because acetaminophen metabolites may interfere with test results, potentially affecting diabetic patient monitoring.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential for assay interference rather than reported injuries, deaths, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or theoretical hazards without reported adverse health consequences.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling five units of ADVIA Chemistry Fructosamine Reagent (FRUC), Material Number 10361941, Lot # 501874. This product is used in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma to monitor blood glucose levels in diabetic patients.
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 lead to inaccurate test results for patients being monitored for diabetes.
The affected product was distributed worldwide and nationwide in the United States, including in numerous states and Puerto Rico. Healthcare facilities and laboratories should stop using the affected lot and contact Siemens for further instructions.
The recalled product
- Product
- ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 5
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)
- Lot # 501874
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.
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