biokitHSV-2 Rapid Test — Class II medical device recall Z-1021-2023
Ongoing recall by Biokit, S.A., reported 2023-02-01, distributed nationwide. HSV-2 rapid test may report false positive results.
| Recall number | Z-1021-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biokit, S.A., Llica D'Amunt, N/A, Spain |
| Recall initiated | 2022-09-28 |
| Classified | 2023-01-26 |
| Reported by FDA | 2023-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 2,393 |
| UPC / GTIN / UDI-DI | 08426951056439 |
| Lot numbers | B34243, B34309, B34463, B34465, B35052, B35188, B35398 |
| Model numbers | 300028001 |
Product
biokitHSV-2 Rapid Test, REF: 300028001
Reason for recall
HSV-2 rapid test may report false positive results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1021-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.