Siemens Atellica CH Fructosamine Reagent Recalled for Potential Carryover
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.
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 2/5 (Moderate).
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: FDA Class II medical device with potential for reagent carryover affecting diagnostic test accuracy. No reported illnesses or injuries have been documented. The hazard is stated as potential rather than confirmed realized harm, placing this at Moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Fructosamine (Fruc) diagnostic reagent due to potential reagent carryover. The affected lot numbers are 211359 and 211451. This issue could impact the accuracy of quality control (QC) testing, patient sample results, and calibrator results. A total of 199 units were distributed globally, including throughout the United States.
The recalled product
- Product
- Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 199
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 (2)
- UDI: 00630414595580
- Lot Numbers: 211359 211451
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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