Wondfo USA Co Ltd: Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medica

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: N/A Lot/code info: part numbers and lot numbers are unknown

Source

Official record: FDA (Device enforcement) ↗

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