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Alinity i hbsag reagent kit
Official notice
8 Jan 2024
Last checked
8 Jan 2024
An official Health Canada notice concerns 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 Published 2024-01-08.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74882
Official notice
2024-01-08
The hazard
The hazard
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
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How to check if you're affected
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Brand: Abbott Laboratories Diagnostics Division, Alinity I Hbsag Reagent Kit.
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