FDAnews Device Daily Bulletin

MHRA Issues Medical Device Alert for Microgen Bioproducts’ Syphilis Tests

Nov. 9, 2011
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.