Atellica CH Enzymatic Hemoglobin A1c assay well-to-well bias
Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.
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 3/5 (High).
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: This is an FDA Class II recall of a diagnostic medical device. The hazard (biased A1c results) is a risk-of-harm scenario involving a high-risk application—blood glucose monitoring that directly affects patient care and treatment decisions—with no reported illnesses or injuries explicitly stated in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc., is recalling the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay (Material Number 11097536, UDI-DI: 00630414220505) due to a potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzers.
The intermittent bias could cause falsely depressed or falsely elevated HbA1c patient results, meaning patients may receive inaccurate hemoglobin A1c measurements. This affects approximately 24,077 units distributed worldwide, including throughout the US and in over 70 other countries.
Customers and healthcare providers using the affected assay should be aware of this potential issue. The FDA classified this as a Class II recall. Affected users should contact Siemens Healthcare Diagnostics, Inc., for further guidance on corrective actions or product replacement.
The recalled product
- Product
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 24,077
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)
- Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.
Distribution
Distributed nationwide across the United States.
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