Epitope Diagnostics, Inc. recalls EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032
Recalled Product
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.
Hazard / Issue
The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.
Issued by
FDA
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