Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

Company / brand

Siemens Healthcare Diagnostics, Inc.

Product

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

Reason / hazard

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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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;

Recall initiated

2026-02-23

Code info

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;

Product quantity

21,291 units (9750 US, 11541 OUS)

Voluntary mandated

Voluntary: Firm initiated

City

Tarrytown

State

NY

Country

United States

Event id

98498

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