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Wondfo USA Co Ltd recalls Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Recalled June 19, 2024 · FDA recall Z-2030-2024 · Wondfo USA
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. · FDA Class II
Units
1,238,755 units
Sold at
US Nationwide distribution.
Description
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.
Product
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Manufacturer(s)
Wondfo USA Co Ltd
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →