Reported Apr 8, 2026 · Ongoing
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
- Siemens Material Number (SMN)11097536
- Lot codes and dates
- Siemens Material Number (SMN)11097536
- UDI-DI00630414220505
- Lot numbers
150131150132150232150260150283150344150361150365150366150445150453150460150498150505150562150600150618150621
- Amount recalled
- 21,291 units (9750 US, 11541 OUS)
Where it was sold
- Nationwide
- GA
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.
This product could cause temporary or reversible health problems — stop using it.
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