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Wondfo USA Co Ltd recalls Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part N
Recalled June 19, 2024 · FDA recall Z-2031-2024 · 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
170,000 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
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
Manufacturer(s)
Wondfo USA Co Ltd
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →