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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-2034-2024 - 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 Medical Supplies LLC, St... 2 06/07/2024 FEI # 3007606081
Wondfo USA Co Ltd
Z-2032-2024 - Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100 2 06/07/2024 FEI # 3007606081
Wondfo USA Co Ltd
Z-2030-2024 - Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 2 06/07/2024 FEI # 3007606081
Wondfo USA Co Ltd
Z-2033-2024 - 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 2 06/07/2024 FEI # 3007606081
Wondfo USA Co Ltd
Z-2031-2024 - 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 Num... 2 06/07/2024 FEI # 3007606081
Wondfo USA Co Ltd
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