Official recall record
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-02-23
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Siemens Healthcare Diagnostics, Inc.
What the authority reported
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
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