Public recall detail

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

2026-06-11

medium
Health products Health product recall
Quick summary

Quick summary: Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software. Reason: Health product recall. Category: Health products. Date: 2026-06-11.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software. Reason: Health product recall. Category: Health products. Date: 2026-06-11.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandHologic, Inc.
ProductAptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-82195

Affected products

ProductAptima HIV-1 Quant Assay
Lotv2.0.0.9
Model7.0.5.7
Serial numberv2.0.0.9
DescriptionAptima HIV-1 Quant Assay
ProductAptima HCV Quant Dx Assay
Lotv2.0.0.9
Model5.5.5.6
Serial numberv2.0.0.9
DescriptionAptima HCV Quant Dx Assay
ProductAptima HBV Quant Assay Kit Software
Lotv2.0.0.9
Model5.4.5.5
Serial numberv2.0.0.9
DescriptionAptima HBV Quant Assay Kit Software

Issue

This notification is to inform Panther and Panther Fusion 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.The Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay software included in assay installer version 2.0.0.9 have not been approved by Health Canada but have been validated and released. Based on this, the configuration does not affect assay performance, compromise the accuracy of test results, or impact product performance.

What you should do

  • Customers will be contacted with instructions to follow.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Immunology
CompaniesHologic, Inc.10210 Genetic Center Drive, San Diego, California, United States, 92121
Recall date2026-05-27
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82195
Background{}
CompaniesHologic, Inc.10210 Genetic Center Drive, San Diego, California, United States, 92121
AudiencesHealthcare
Source updated2026-06-11

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...