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Wondfo USA Co Ltd FDA Recalls
5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10Class IIApr 22, 2024Wondfo USA has identified unauthorized distribution of the P |
| Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home MediClass IIApr 22, 2024Wondfo USA has identified unauthorized distribution of the P |
| Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part NClass IIApr 22, 2024Wondfo USA has identified unauthorized distribution of the P |
| Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo BioteClass IIApr 22, 2024Wondfo USA has identified unauthorized distribution of the P |
| Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO StrClass IIApr 22, 2024Wondfo USA has identified unauthorized distribution of the P |