FDA Device recall Z-1021-2023
biokitHSV-2 Rapid Test, REF: 300028001
- FDA Device
- Class II
- ongoing
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of biokitHSV-2 Rapid Test, REF: 300028001 by Biokit, citing HSV-2 rapid test may report false positive results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1021-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-28 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biokit |
| Distribution | US |
Product
biokitHSV-2 Rapid Test, REF: 300028001
Reason
HSV-2 rapid test may report false positive results.
Identifiers
| code_info | UDI-DI/Lots - Expiration Dates: 08426951056439/ B34243 - 2022-09-30, B34309 - 2022-11-30, B34463 - 2022-11-30, B34465 -…UDI-DI/Lots - Expiration Dates: 08426951056439/ B34243 - 2022-09-30, B34309 - 2022-11-30, B34463 - 2022-11-30, B34465 - 2023-02-28, B35052 - 2023-05-31, B35188 - 2023-07-31, B35398 - 2023-10-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1021-2023%22
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