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

Recall date

October 1, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0426-2021

FDA classification

Class II

Brand / firm

Epitope Diagnostics, Inc.

Sold / distributed

U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.