MHRA Issues Medical Device Alert for Microgen Bioproducts’ Syphilis Tests

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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for Microgen Bioproducts’ Mercia Syphilis M kit due to higher level of non-specific cross-reactivity. This can lead to a false positive diagnosis of syphilis IgM, which was observed with lot nos. 052X1, 053X1 and 05411A.