Atellica CH Enzymatic Hemoglobin A1c (A1c_E) Assay Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Siemens Healthcare Diagnostics Inc. is recalling the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay due to potential intermittent well-to-well bias that may cause inaccurate patient results.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on July 16, 2026 and geographically references Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, Diagnostic-Assay.
What Happened
Siemens Healthineers has confirmed through internal investigation of 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. This observed bias does not affect every A1c_E reagent lot or reagent pack. Affected wells cannot currently be identified prospectively, therefore all in-date lots are considered potentially impacted. Under certain circumstances, this issue may result in falsely depressed patient results when lot calibration is performed using an affected well and patient testing is subsequently performed using an unaffected well, or falsely elevated patient results when lot calibration is performed using an unaffected well and patient testing is subsequently performed using an affected well.
Which Products Are Affected
- Product: Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay
- Model or catalogue number: 11097536
- Lot or serial number: All lots
- Company: Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, New York, United States, 10591
What You Should Do
No specific consumer action steps are provided in the recall notice. Users should refer to the full Health Canada alert for additional guidance.
Why This Matters
The potential for inaccurate hemoglobin A1c test results may affect patient management when using the affected assay on Atellica systems.
Source
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,549 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 16, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.