Hazard description
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.
RecallTracker