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Woodside Acquisitions Inc Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA
Woodside Acquisitions Inc. is recalling these tests because they were distributed in the U.S. without authorization, clearance, or approval from the FDA. Woodside Acquisitions Inc. did not provide the FDA with adequate validation data to show that the performance of these tests is accurate, and there is a risk of potential false negative, false positive, or misinterpretation of results.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Questions?
If you have questions about this recall, contact Woodside Acquisitions Inc. at woodsideinc.pa@gmail.com or call 814-218-2804.
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