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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Siemens Healthcare Diagnostics
- Product type
- Clinical Chemistry Analyzer Module
- Model numbers
- SMN 11097536, UDI-DI 00630414220505
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 23, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
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
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)
- 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
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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
- Lot numbers 150131-150621 affected
- A1c_E bias linked to RCRP on same analyzer
- Depressed results may delay diabetes diagnosis or impact treatment
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Safety Guide
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