| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01091-1 |
| Product Name/Description |
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay. An in vitro diagnostic medical device
Product Code: PRD-07400 (ASY-16066)
ARTG 296043
(Hologic (Australia & New Zealand) Pty Ltd - Multiple-viruses IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Hologic has been made aware of potential erroneous influenza B virus (Flu B) positive results when testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay on the Panther Fusion System. When testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay, there is a potential risk of a false Flu B positive result in samples that are also SARS-CoV-2 positive.
Occurrence of this issue does not impact test results for the other analytes in the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers may continue to test with the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay on the Panther Fusion System.
If a customer suspects a false Flu B positive result in combination with SARS-CoV-2 positive result (dual positive), please contact Hologic Technical Support for evaluation and/or troubleshooting.
Customers may identify samples that have been affected by this issue by reviewing the associated amplification curves on the Panther Fusion system. In reviewing the curves, the atypical amplification curve for Flu B may appear unusually “flat”.
Hologic will be in touch when a permanent solution is available. |
| Contact Information |
02 9888 8000 - Hologic |