Aptima HIV Quant Dx Assay Software Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Health Canada issued a recall notification for Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay software installed prior to approval.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on June 29, 2026 and geographically references National. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, assay.
What Happened
Hologic, Inc. notified users that assay installer version 2.0.0.9, including the Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay software, was installed on Panther and Panther Fusion systems prior to Health Canada approval.
Which Products Are Affected
- Aptima HIV-1 Quant Assay, v2.0.0.9, model 7.0.5.7
- Aptima HCV Quant Dx Assay, v2.0.0.9, model 5.5.5.6
- Aptima HBV Quant Assay Kit Software, v2.0.0.9, model 5.4.5.5
The affected software was released by Hologic, Inc., 10210 Genetic Center Drive, San Diego, California, United States, 92121.
What You Should Do
No action is specified in the recall notification.
Why This Matters
The software has not been approved by Health Canada, though the company states it has been validated and does not affect assay performance or test result accuracy.
Source
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (997 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to June 29, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.