Atellica CH Enzymatic Hemoglobin A1c recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIOngoing
Summary: Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;. Reason: 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 is being recalled
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Why
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 serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Domestic: Nationwide Distribution International: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic , Denmark , Ecuador, Egypt , Estonia , Finland , France , Georgia , Germany , Greece , Hong Kong, India, Iraq , Italy , Jordan , Kuwait , Latvia , Lithuania , Macedonia , Malaysia, Maldives, Mexico, Netherlands , New Zealand, Norway , Oman , Pakistan , Paraguay, Qatar , Romania , Saudi Arabia , Serbia , Singapore, Slovakia , Slovenia , South Africa, South Korea, Spain , Turkey , Turkmenistan , U.A.E. , Uganda , United Kingdom , Uruguay , Vatikancity; (states named: Georgia)
How to tell if yours is affected
Siemens Material Number (SMN): 11097536; UDI-DI: 00630414220505; Lot numbers: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1657-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 23, 2026 |
| Reported | April 8, 2026 |
| Company | Siemens Healthcare Diagnostics, Inc. |
| Company location | Tarrytown, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 21,291 units (9750 US, 11541 OUS) |
More recalls from Siemens Healthcare Diagnostics, Inc. · all medical device recalls · recalls from February 2026