🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: February 23, 2026 Siemens Healthcare Diagnostics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1657-2026

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