Panther System
Brand(s)
Last updated
Summary
Product
Panther System
Issue
Medical devices - Performance
What to do
Company has notified customer of this situation, and allowed for software update.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Panther System | Not applicable. | 303095 |
Issue
According to the assay package inserts for the following Aptima assays: HIV-1 Quant DX, HBV Quant, HCV Quant DX, CMV Quant, BV, and CV/TV, controls from different lot numbers can be used. However, Hologic has identified a software anomaly with Panther/Fusion SW version 7.2.9, where assay processing will not start when the control lots loaded on the Panther/Panther Fusion system do not match the ones listed on the control barcode sheet.
Recall start date: November 17, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
| Hologic, Inc. |
| 10210 Genetic Center Drive, San Diego, California, United States, 92121 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75066
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