Alinity I HBsAg Reagent Kit

Abbott has identified a few cartridges within Alinity I HBsAg reagent kit, list number 08P0852, lot 51503FN00 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.

Recall start date: December 21, 2023