Ortho received complaints and confirmed that there is potential for deformed Versatip with lot 1039734. this deformity can lead to an improper seal of the tip on the Proboscis. an improperly sealed tip may cause a condition code to post but will not always post a condition code or suppress result reporting. This issue does not impact microslide assay results. However, it has potential to cause a positive or negative bias in some microtip and microwell infectious disease assays leading to false positive or false negative results for samples with borderline signal cutoff values. Recall start date: 2021-12-14
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