Safety Alerts

Health Canada has posted a medical device safety alert concerning Abbott Ireland Diagnostics Division Alinity I HBsAg Reagent Kit [Model / Catalog Number: 08P0852; Lot / Serial Number: 51503FN00] [HKMD No.: 190362].

According to the Health Canada, the manufacturer has identified a few cartridges within Alinity I HBsAg reagent kit that may exhibit variability in relative light unit (RLU) response and concentration values which may result in controls out of range, and/or incorrect patient results. Positive control out of range low results and/or negative control out of range high results could occur when using an impacted cartridge. Per the instructions for use (IFU), controls are required to be run once within each 24 hours of use. A potential falsely decreased or falsely increased patient result may occur for any of the following scenarios:

1. An impacted cartridge was used without running controls.
2. An impacted cartridge was used following calibration with a non-impacted cartridge.
3. An impacted cartridge was successfully calibrated, and controls were within range but calibrator and/or control RLUs are low.

For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/alinity-hbsag-reagent-kit

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 9 Jan 2024