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Epitope Diagnostics Recalls

1 recall on record · November 18, 2020 to November 18, 2020 · Medical Devices

November 18, 2020Medical DevicesFDA

Epitope Diagnostics, Inc. recalls EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection

Hazard: 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.

Epitope Diagnostics Recalls | RecallWatchUSA