Medical device recalls Moderate risk

Biokit, S.A. recalls biokitHSV-2 Rapid Test, REF: 300028001

Recall date
September 28, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1021-2023
FDA classification
Class II
Brand / firm
Biokit, S.A.
Sold / distributed
US Nationwide distribution in the states of NY, CA, IN, NC, VA.

Why it was recalled

HSV-2 rapid test may report false positive results.

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

What was recalled

biokitHSV-2 Rapid Test, REF: 300028001

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