Medical device manufacturer, BD, has issued a medical device safety alert concerning its BD MAX Vaginal Panel [Catalogue number: 443712, 443710] and BD MAX UVE Specimen Collection Kit [Catalogue number: 443376].
The manufacturer is currently conducting an investigation into customer complaints regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
Data from the investigation suggest that this issue is related to certain specimen collection practices, including the use of lubricants. Information is intended to provide clinicians and patients with precautions in relation to current Package Insert instructions included with BD MAX UVE Specimen Collection Kits.
Product returns or discards are not required.
Clinicians and patients are advised to follow the precautions provided by the manufacturer.
According to the local supplier, the affected products are distributed in Hong Kong
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 July 2017