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

FDA device recall Z-1657-2026 · posted 2026-03-27 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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.

Action taken

On February 23, 2026 Urgent Medical Device Correction letters were sent to customers. Actions required: If your laboratory is not processing RCRP and A1c_E on the same analyzer, no action is required. If your laboratory is processing RCRP and A1c_E on the same analyzer, monitor A1c_E QC for evidence of negative bias and increased imprecision. Please review this letter with your Medical Director to determine the appropriate course of action, including evaluation of any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Retain this letter with your laboratory records and forward it to others who may have received this product. Resolution A follow-up communication will be provided when Customer Actions are no longer required. We appreciate your continued partnership and apologize for any inconvenience this situation may cause. If you have any questions or require assistance, please contact your Siemens Healthineers Customer Care Center or your local technical support representative.

Root cause

Process control

Status

Open, Classified

Product code

PDJ

Quantity affected

21,291 units (9750 US, 11541 OUS)

Distribution

Domestic: Nationwide Distribution International: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic , Denmark , Ecuador, Egy

Date initiated

2026-02-23

Date posted

2026-03-27

Location

Tarrytown, NY

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