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 read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, health-canada, assay) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
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 ↗
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Common questions about this Health Canada recall.