Siemens Healthineers Recalls DCA Vantage HbA1c Test Cartridges Over Faulty Results

Health Canada has issued a health product recall for a lot of Siemens Healthineers DCA Vantage® HbA1c (DX Claim) test cartridges after the company confirmed a manufacturing defect that can cause inaccurate diabetes test results. The recall, published on July 22, 2026, affects cartridges used with the DCA Vantage analyzer in clinical and point-of-care settings across Canada.

What Products Are Being Recalled?

The recall covers the ‘DCA Vantage® HbA1c (DX Claim)’ cartridge, manufactured by Siemens Healthcare Diagnostics Inc. The affected lot number is 0916065, corresponding to model or catalogue number 10698915. These cartridges are used with the DCA Vantage analyzer to measure HbA1c levels, a key blood marker used to monitor and diagnose diabetes.

Why Was This Recall Issued?

Siemens Healthineers confirmed through customer complaint investigations and internal testing that a small subset of cartridges in the affected lot may experience ‘delamination’ of the buffer pull-tab. This occurs when bonded material layers within the pull-tab separate, preventing the buffer solution from fully releasing into the reaction chamber and reducing the reagent volume available for analysis.

When this happens, the analyzer may produce falsely low, or negatively biased, HbA1c results, or it may generate an error code that prevents the test from completing at all. According to the company, the issue has been observed in approximately 0.07 to 0.5 percent of cartridges within the affected lots, meaning the large majority continue to perform as intended. However, even a small error rate can be significant in a diagnostic test used to guide treatment decisions for diabetic patients.

Who Is Affected?

This recall affects healthcare providers, clinics, laboratories, and point-of-care testing sites in Canada that use the DCA Vantage analyzer with cartridges from lot 0916065. Patients whose HbA1c levels were tested using an affected cartridge could potentially receive an inaccurately low reading, which may affect clinical decisions about diabetes management if the result is not flagged as an error and is used without confirmation.

What Should You Do?

Health Canada advises the following steps for anyone using the affected product:

• Check inventory for cartridges from lot number 0916065, model or catalogue number 10698915.
• Contact Siemens Healthcare Diagnostics Inc. directly if additional information or guidance is required regarding the affected lot.
• Healthcare providers should be alert to unexpected instrument error codes or unusually low HbA1c readings and consider retesting with an unaffected cartridge if a result seems inconsistent with a patient’s clinical picture.
• Continue to follow standard laboratory quality control procedures when using DCA Vantage cartridges from the affected lot.

The recall notice does not indicate a broader market withdrawal is required for cartridges outside the specified lot, and the majority of cartridges in the affected lot are expected to function normally.

Official Statement

According to Health Canada’s published recall notice, ‘delamination occurs when bonded material layers within the pull-tab separate, preventing full release of the buffer solution into the reaction chamber and reducing the reagent volume available for analysis.’ The notice further states that ‘the majority of the cartridges in these lots continue to perform as intended.’ The recall is classified as a Type II health product recall, with an identification number of RA-82378, published by Health Canada on July 22, 2026.