bioMerieux SA, 5731, VIDAS Anti-HEV IgM

Following complaints from the field for false positive results when using some lots of VIDAS® Anti-HEV IgM (HEVM), bioMérieux initiated an investigation to assess product issue and identify the root-cause, While the investigation is still ongoing the followings were identified:

The analysis of data retrieved from some impacted customers and tests performed internally allowed to highlight five lots (listed in Table 1) that potentially gave false positive results with patient samples. The issue occurred only with some specific patient samples. The tests done on internal samples gave conform results. The investigation identified a potential root cause that is non-specific binding to the Solid Phase Receptacle with some patient samples associated to a common raw material (specific peptide lot) used for the manufacturing of these five lots. The tests done with other lots of VIDAS® Anti-HEV IgM (HEVM) manufactured with another raw material have confirmed that these lots are still conform to the product specifications. Consequently, you can be confident in using other lots of VIDAS® Anti-HEV IgM (HEVM) available on the market.