Siemens Atellica CH Hemoglobin A1c Assay Recall Canada 2026

Health Canada has issued a Type II recall for the Siemens Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay, a diagnostic medical device used in clinical laboratories to measure blood sugar control in patients. The recall, identified under reference number RA-82220, was initiated on June 10, 2026, and covers all in-date lots of the product under catalogue number 11097536. The issue involves a performance defect that may produce inaccurate hemoglobin A1c test results, potentially compromising patient care decisions related to diabetes management.

What Products Are Being Recalled?

• Product: Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay
• Brand: Siemens Healthcare Diagnostics Inc.
• Catalogue Number: 11097536
• Lot Numbers: All lots
• Systems Affected: Atellica CH and Atellica CI analyzer systems

The product is a reagent-based assay used by healthcare laboratories to perform enzymatic testing of hemoglobin A1c (HbA1c), a key biomarker for monitoring long-term blood glucose levels in diabetic patients.

Why Was This Recall Issued?

Siemens Healthineers confirmed, through an internal investigation triggered by customer complaints, the potential for intermittent well-to-well bias affecting the A1c_E/A1c_H assay when used on the Atellica CH and Atellica CI systems. The bias does not affect every reagent lot or reagent pack, but since affected wells cannot be identified in advance, all in-date lots are considered potentially impacted until further notice.

• Falsely depressed results: May occur when lot calibration is performed using an affected well and patient testing is subsequently performed using an unaffected well.
• Falsely elevated results: May occur when lot calibration is performed using an unaffected well and patient testing is subsequently performed using an affected well.

Inaccurate HbA1c readings can directly affect clinical decisions regarding diabetes treatment, potentially leading to over- or under-treatment of patients.

Who Is Affected?

This recall affects clinical laboratories, hospitals, and diagnostic centres across Canada that use the Siemens Atellica CH or Atellica CI analyzer systems with the A1c_E assay reagent kits. Healthcare professionals relying on these test results for patient diabetes management decisions are directly impacted. Patients whose HbA1c levels were tested using potentially affected lots may have received inaccurate results.

The recall audience includes the general public, healthcare providers, and the diagnostic industry. Health Canada has classified this as a Type II recall, indicating that use of the product may cause temporary adverse health consequences, or where the probability of serious adverse health consequences is remote.

What Should You Do?

• Laboratories and healthcare facilities using the Atellica CH or Atellica CI systems with the A1c_E assay should contact Siemens Healthcare Diagnostics Inc. immediately for guidance.
• Do not continue using potentially affected reagent lots until you have received updated instructions from the manufacturer.
• Review any recently issued HbA1c test results that may have been processed using the affected assay and consult with clinical staff about retesting where appropriate.
• Contact Siemens Healthcare Diagnostics Inc. at their registered address: 511 Benedict Ave, Tarrytown, New York, United States, 10591, for additional information and product replacement or remediation options.
• Healthcare professionals should also report any adverse events related to this device to Health Canada.

Official Statement

According to Health Canada, Siemens Healthineers confirmed through internal investigation of customer complaints the potential for intermittent well-to-well bias affecting the A1c_E assay. The regulator notes that all in-date lots are considered potentially impacted until further notice, as affected wells cannot currently be identified prospectively. Health Canada published this alert on June 18, 2026, and advises affected parties to contact the manufacturer for additional information. This recall is published under the authority of Health Canada and is classified as a health product recall in the medical devices – chemistry category.