Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software
Brand(s)
Last updated
Summary
Product
Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software
Issue
Medical devices - Unauthorised device
What to do
Customers will be contacted with instructions to follow.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Aptima HIV-1 Quant Assay | v2.0.0.9 | 7.0.5.7 |
| Aptima HCV Quant Dx Assay | v2.0.0.9 | 5.5.5.6 |
| Aptima HBV Quant Assay Kit Software | v2.0.0.9 | 5.4.5.5 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Immunology
Companies
| Hologic, Inc. |
| 10210 Genetic Center Drive, San Diego, California, United States, 92121 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82195
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