Siemens Atellica CH Fructosamine Reagent Recalled for Acetaminophen Interference
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine Reagent because acetaminophen metabolites may interfere with test results.
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 does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score involving potential interference without confirmed harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 26 units of Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580. The product is used in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two to three weeks.
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. The affected lot numbers are 291011 and 201115.
The 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 reagent and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding tw
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 26
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 # 291011 ***Added 9/9/20*** 201115
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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