Public recall detail

Panther System

2024-02-13

medium
Recall Safety notice
Quick summary

Quick summary: Panther System. Date: 2024-02-13.

Recommended action

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

Recall details

Quick summary: Panther System. Date: 2024-02-13.

Official details

Affected product details

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

BrandHologic, Inc.
ProductPanther System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75066

Affected products

ProductPanther System
LotNot applicable.
Model303095
Serial numberNot applicable.
DescriptionPanther System

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

What you should do

  • Company has notified customer of this situation, and allowed for software update.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesHologic, Inc. 10210 Genetic Center Drive, San Diego, California, United States, 92121
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75066
Background{}
CompaniesHologic, Inc. 10210 Genetic Center Drive, San Diego, California, United States, 92121
AudiencesHealthcare
Source updated2024-02-13

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

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