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FDAnews Device Daily Bulletin
MHRA Issues Medical Device Alert for Microgen Bioproducts’ Syphilis Tests
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.
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