Atellica CH Enzymatic Hemoglobin A1c Assay
Siemens is recalling the Atellica CH A1c_E assay due to a risk of depressed results when used alongside the RCRP assay on the same analyzer.
Review your laboratory workflow to determine if A1c_E and RCRP assays are being processed on the same analyzer. If they are, discontinue this practice immediately and process these assays on separate analyzers. Monitor Quality Control results for negative trends or increased imprecision.
Recall at a glance
- Quantity recalled
- 21,291 units (9750 US, 11541 OUS)
Why it was recalled
Siemens Healthcare Diagnostics is recalling the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay because processing it on the same analyzer as the Atellica CH RCRP assay can cause depressed results. This negative bias and increased imprecision may lead to delayed diabetes diagnosis or suboptimal treatment. The product was distributed nationwide.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
- UDI-DI
- 11097536, 00630414220505
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Siemens Healthcare Diagnostics, Inc.
Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification