Class II — Biokit, S.A.
| Recalling firm | BIOKIT S.A. |
|---|---|
| Registered facility | BIOKIT S.A. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | HSV-2 rapid test may report false positive results. |
| Product | biokitHSV-2 Rapid Test, REF: 300028001 |
| Quantity | 2,393 |
| Distribution | US Nationwide distribution in the states of NY, CA, IN, NC, VA. |
| Initiated | 2022-09-28 |
| Classified | 2023-01-26 |
| Recall number | Z-1021-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biokit, S.A. (Z-1021-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91384/
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