Medical device manufacturer, BioMerieux, has issued a medical device safety alert concerning its VIDAS Anti-HBs Total II [Reference: 30318; Lot #: 1007271590, 1007160480, 1007180650, 1007366810, 1007366780, 1007421640, 1007439690, 1007448880, 1007505320, 1007539450, 1007568420, 1007579920, 1007600880, 1007754100, 1007889620, 1008235530, 1008443310, 1008552810]
According to the manufacturer, its investigation of the complaints with results identified as false positive by the customers did not confirm a degraded global specificity for the product. However, it showed unexpected interferences (cross reactions) that had not been described in the Instructions for Use and that could lead to false positive results. To reduce the interference, the composition of the washing buffer of the strip has been modified by the manufacturer to decrease non-specific bindings and therefore decrease the risk of false positive results. The new formulation will be released in the coming weeks.
The manufacturer is advising users to stop using and destroy the affected lots of the product.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 Jun 2021