What is the product affected by this recall?

The Atellica CH Enzymatic Hemoglobin A1c A1c_E module on Siemens Healthineers systems (SMN 11097536) is affected. Lot numbers include 150131 through 150621.

Who is impacted by this recall?

Clinical laboratories using the Atellica CH A1c_E module on the same analyzer as RCRP may experience biased results. Labs using separate analyzers are not impacted.

A depressed A1c_E result bias with increased imprecision can delay diabetes diagnosis or lead to suboptimal treatment.

What should I do now if we use this device?

Stop using the affected device and follow Siemens recall instructions. Contact Siemens or your lab's leadership for remediation steps.

How many units are recalled?

21,291 units are affected worldwide, including 9,750 in the US and 11,541 outside the US.

Where can I find more information?

Refer to the FDA recall page linked in the notice and Siemens’ official communications.

Will Siemens provide replacements or refunds?

Siemens indicates remediation and follow-up instructions will be provided by the manufacturer. Refer to the recall notice for specifics.

Are there any immediate safety steps for laboratories?

Yes. Stop using the affected modules on shared analyzers until guidance is issued by Siemens.

What about QC procedures?

Labs should monitor QC trends for negative bias and increased imprecision and escalate to Siemens with data.

How long will remediation take?

Replacement or remediation timelines vary; labs should expect weeks to months depending on stock and service arrangements.

HIGHFebruary 23, 2026

Siemens Healthcare Diagnostics Atellica CH A1c_E Recall for 21,291 Units (2026)

Siemens Healthcare Diagnostics recalled 21,291 Atellica CH A1c_E units distributed to laboratories nationwide and internationally in 2026. The recall addresses a depressed result bias when A1c_E is processed with RCRP on the same analyzer. Labs using separate analyzers are not impacted. Stop using the affected module immediately and follow manufacturer instructions. Contact Siemens or your lab’s F

Quick Facts at a Glance

Recall Date: February 23, 2026
Hazard Level: HIGH
Brand: Siemens Healthcare Diagnostics
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Healthcare Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Atellica CH system by Siemens provides automated clinical chemistry testing, including HbA1c measurements for diabetes monitoring. The A1c_E enzymatic assay is used to determine HbA1c levels in patient samples.

Why This Is Dangerous

The recall describes a potential depressed result when A1c_E is processed with RCRP on the same analyzer. A negative bias and worsening imprecision over time can mislead clinical decisions.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Labs may need to re-test samples, rerun QC, and adjust patient management plans. Delays in diabetes diagnosis and treatment adjustments are possible for affected runs.

Practical Guidance

How to identify if yours is affected

Confirm the analyzer is an Atellica CH with A1c_E module (SMN 11097536)
Check lot numbers against 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621
Determine if A1c_E is processed on the same analyzer as RCRP
If affected, discontinue use of the affected module on that analyzer
Contact Siemens Healthcare Diagnostics for remediation guidance
Document results and actions taken

Where to find product info

Recall notice and FDA enforcement report at the provided link; Siemens’ recall communications

What timeline to expect

Remediation timelines vary; units recalled total 21,291 with US 9,750 and international 11,541

If the manufacturer is unresponsive

Escalate to hospital procurement and laboratory leadership
Request escalation to Siemens recall support
If no resolution within 2-4 weeks, contact the FDA recall office for guidance

How to prevent similar issues

Avoid sharing A1c_E modules between analyzers
Ensure proper IFU alignment for A1c_E and RCRP processing
Maintain up-to-date QC practices and trend analysis
Verify replacements or remediation steps before reintroducing modules

Documentation advice

Maintain inventory list with SMN, lot numbers, and recall communications; preserve QC data and correspondence with Siemens; document patient impact when applicable

Product Details

Model numbers: 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. Sold domestically nationwide and internationally to laboratories. Sold from unknown start date. Price not disclosed.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

21,291 units recalled
SMN 11097536 listed
Lot numbers 150131-150621 affected
A1c_E bias linked to RCRP on same analyzer
Depressed results may delay diabetes diagnosis or impact treatment

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeClinical Chemistry Analyzer Module

Product Details

Brand

Siemens Healthcare Diagnostics

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