Siemens Atellica CH Ethyl Alcohol Assay Recalled for Calibration Bias
Siemens Healthcare Diagnostics is recalling Atellica CH Ethyl Alcohol assays due to potential positive bias in results within the 10-day calibration interval.
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: The recall is classified as FDA Class II, but the source text describes a potential positive bias in results without reporting any specific patient injuries, hospitalizations, or deaths. This aligns with a moderate severity rating for a diagnostic accuracy issue where harm is theoretical or indirect.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Ethyl Alcohol assay (Test Code ETOH, SMN 11097501) for in vitro diagnostic (IVD) use. The recall involves 1,124 units distributed domestically in the United States and internationally to numerous countries including Australia, Canada, Germany, Japan, and the United Kingdom.
The recall was initiated because the assay may exhibit a positive bias in quality control and patient results within the 10-day pack calibration interval. This issue could lead to inaccurate ethyl alcohol measurements. The affected lots include 190133, 190222, 100066, and 100168.
Healthcare facilities and laboratories using this product should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions or replacement. Patients who have had ethyl alcohol tests performed using these specific lots may wish to consult their healthcare provider regarding the potential impact on their results.
The recalled product
- Product
- Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,124
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)
- All in-date lots: 190133
Distribution
Distributed nationwide across the United States.
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