During an internal investigation, Ortho identified that the Anti-Lea (Anti-Le1) lot LAB170A was demonstrating weak to no reactivity with Lea positive cells. The results of the investigation demonstrated that lot LAB170A was more than two dilutions lower than the control lot, thereby these lots were failing internal testing. This issue of weak/no reactivity of Anti-Lea (Anti-Le1) antisera may be detectable in both quality control (QC) and patient samples based on weakened strength of reactivity. Recall start date: June 29, 2022
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