Medical device manufacturer, DiaSorin S.p.A. has issued a field safety notice concerning Liaison Biotrin Parvovirus B19 IgM (Catalogue number 317010 and lot number: 129014X, 129014X/1, 129015X and 129015X/1).
Through internal testing, DiaSorin has become aware that the kit lots identified above have a potential to produce an increased rate of positive results.
The manufacturer recommends the affected users to retest all initially reactive specimens unless, as part of the laboratory policy, these samples have already been confirmed by other method or by clinical evidence. The manufacturer is offering Parvovirus B19 IgM EIA, code V619IM free of charge to perform the retesting.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 12 December 2012