FDA Device recall Z-2030-2024
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
- FDA Device
- Class II
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class II recall of Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 by Wondfo Usa, citing wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2030-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-22 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Wondfo Usa |
| Distribution | US |
Product
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Reason
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Identifiers
| code_info | a) PRE-STA-25, UDI/DI **, Lot Numbers: W03921102, W039301003, W039301005, W039301004, W039309003, W039309007, W0391090…a) PRE-STA-25, UDI/DI **, Lot Numbers: W03921102, W039301003, W039301005, W039301004, W039309003, W039309007, W03910902, W03911002, W03910911, W03921005, W03921102, W03921008, W039212001, W039212006, W03920804; b) PRE-STA-10, UDI/DI **, Lot Numbers: W03920902, W03921103, W039307002, W039306008, W03931002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2030-2024%22
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