FDA Device recall Z-2031-2024
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) C…
- FDA Device
- Class II
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class II recall of Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) C… 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-2031-2024 |
| 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
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
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) CD-STP25, Lot Numbers: W03920402, W03920603, W03920707, W03921002, W03921006, W039301001, W039302001, W039302003, W…a) CD-STP25, Lot Numbers: W03920402, W03920603, W03920707, W03921002, W03921006, W039301001, W039302001, W039302003, W039306003; b) CD-STP25V, Lot Numbers: CD-STP25V W03920404, W039302002 |
|---|
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-2031-2024%22
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