Health Canada18 Jun 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay
Health Canada published a recall notice for Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay on 18 Jun 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 18 Jun 2026
- Recall type
- Health product recall
- Companies
- Siemens Healthcare Diagnostics Inc.511 Benedict Ave, Tarrytown, New York, United States, 10591
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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. However, affected wells cannot currently be identified prospectively, therefore all in-date lots are considered potentially impacted until further notice. 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.. Falsely elevated patient results when lot calibration is performed using an unaffected well and patient testing is subsequently performed using an affected well. Additional information Details Original published date: 2026-06-18 Affected products: Affected products Lot or serial number Model or catalogue number Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay All lots. 11097536 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.