Atellica CH Enzymatic Hemoglobin A1c Assay
Siemens is recalling the Atellica CH A1c_E assay due to potential depressed results when processed alongside RCRP 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.
Why it was recalled
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.
How to identify it
UPC 11097536 00630414220505
Atellica CH Enzymatic Hemoglobin A1c (A1c_E);
Where it was sold
Distributed in US.
Official source
Other recent recalls from Siemens Healthcare Diagnostics, Inc.
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification