Hologic Aptima HPV Assay Recall - False Negative Results

Hologic initiated a Class II recall for its Aptima HPV Assay after identifying that the product may generate invalid or false negative results. FDA classified this as a Class II recall, indicating potential temporary or reversible health consequences if the assay's diagnostic performance is compromised. The affected product was distributed to healthcare facilities and laboratories in nine states.

Healthcare providers and clinical laboratories that have used this assay must immediately discontinue use of the affected product, quarantine remaining inventory, and conduct a clinical assessment to determine whether any patient results may have been impacted by false negative findings. Delayed or missed HPV detection can lead to delayed follow-up care for patients at risk. Hologic is responsible for coordinating the recall and providing replacement or corrective product.