FDA Device recall Z-2033-2024
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Par…
- FDA Device
- Class II
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class II recall of Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Par… 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-2033-2024 |
| 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
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
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 | Lot Numbers: W039301002, W039306002, W039312001, W03920403, W03920708, W03921003, W03921007 |
|---|
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-2033-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.