Alinity I Homocysteine Reagent Kit

Issue

The purpose of this notification is to inform you of a product correction for the Alinity I Homocysteine Reagent Kits listed in the letter. Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of quality control results. If your laboratory has established statistically‐based control limits at each clinically relevant control level, your controls will detect the shift out of range. If quality control results do not meet the acceptance criteria defined by your laboratory, sample results may be suspect and should not be reported. Recall start date: Mar 25, 2022

What you should do

• Contact the manufacturer if you require additional information.