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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