CanadaDCA Vantage® HbA1c (DX Claim) test cartridges (catalogue number 10698915, lot 0916065) are affected. A small subset (about 0.07–0.5% in these lots) may have delamination of the buffer pull-tab that can prevent full release of buffer into the reaction chamber, potentially causing falsely low HbA1c results or instrument error codes. Contact the manufacturer, Siemens Healthcare Diagnostics Inc., for additional information.
What's being recalled
Companies: Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, New York, United States, 10591.
How to identify it
Affected products: DCA Vantage® HbA1c (DX Claim); Lot or serial number: 0916065; Model or catalogue number: 10698915
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)