Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Bio-Rad, has issued a medical device safety alert concerning its Geenius HIV 1/2 Confirmatory Assay [Catalog Number: 72460; Batch: 3A0054] [HKMD No.: 200268].
The manufacturer is informing users that an anomaly is caused by a plastic artifact, potentially present in the reading window (visible to the naked eye), that may affect the global band detection by the Geenius reader and impact final interpretation of the result. The reader can incorrectly display an indeterminate or, in rare cases, a negative result.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 May 2023