Medical device manufacturer, Beckman Coulter Inc., issued a medical device safety alert concerning its ACCESS SARS-CoV-2 IgG (1st IS) Reagent: C74339 [All Lots], ACCESS SARS-CoV-2 IgG (1st IS) Calibrator: C74340 [All Lots]. and ACCESS SARS-CoV-2 IgG (1st IS) Quality Control: C74341 [All Lots].
The manufacturer has determined that in remote circumstances the Access SARS-CoV-2 IgG (1st IS) assay may generate discordant results when compared to other World Health Organization (WHO) traceable assays.
The manufacturer will be updating the Access SARS-CoV-2 IgG (1st IS) product labelling to reflect this information. A retrospective review of patient test results obtained with the Access SARS-CoV-2 IgG (1st IS) assay is not required. Any review is left to the discretion of the Laboratory Medical Director. Affected users are advised to include information similar to the following in test reports:
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 action.
Posted on 16 Sep 2021