Medical device manufacturer, Hologic, has issued a medical device safety alert concerning its Panther Fusion Tube Trays [Part No. FAB-15004, Box Lot number: 285762, 285765, 286025, 286026, 286028, 286852, 287410, 289297, 290057, 290064, 290068, 290409, 291425; Catalog No. PRD-04000, Box/Tray Lot Number: 647288, 648958, 648959, 650655, 650656, 654832, 654833, 657545; Distribution Dates: 02 Dec 2020 to 10 Feb 2021].
The manufacturer has identified specific lots of tube trays that have a low risk of leaking. It could potentially result in false positive results, false negative results, or invalid patient results or assay worklists, in the Panther Fusion assays (SARS-CoV-2, Flu A/B/RSV, Paraflu, AdV/hMPV/RV, Bordetella, MRSA and GBS) and Laboratory Developed Tests using the Open Access functionality of the Panther Fusion System.
The manufacturer advised affected users to identify, segregate and discontinue use of the affected products.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 3 March 2021