Aptima Hiv Quant Dx Assay, Hcv Quant Dx Assay, And Hbv Quant Assay Software

Hologic is recalling Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software across Canada because these devices were not authorized for sale in the country. This recall affects medical facilities and laboratories that use these blood-testing products to measure HIV, hepatitis C, and hepatitis B virus levels. The recall is classified as Class II, indicating a potential health risk but not an immediate life-threatening situation.

Product

Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software

Reason

Unauthorised device

Classification

Class II

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-06-11

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0a97a4d7-f737-4eb0-83bf-6af6462a72fc