Recall MonitorHealth Products
DCA Vantage® HbA1c (DX Claim)
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Haematology
Product: DCA Vantage® HbA1c (DX Claim)
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| DCA Vantage® HbA1c (DX Claim) | 0916065 | 10698915 |
Issue
Siemens Healthineers has confirmed through customer complaint investigation and internal testing that delamination of the buffer pull-tab may occur in a small subset of cartridges. 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.When delamination occurs, it may result in falsely low (negatively biased) HbA1c results or instrument-generated error codes that prevent completion of the test. The issue observed in approximately 0.07-0.5% of cartridges in these lots. The majority of the cartridges in these lots continue to perform as intended.