Wondfo USA Co Ltd: 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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 102,500 units Lot/code info: Lot Numbers: W039301002, W039306002, W039312001, W03920403, W03920708, W03921003, W03921007

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.