Woodside Acquisitions Inc. is recalling Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits 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. The use of these devices may cause serious injuries, serious health consequences, or death.
For more information about the recall, click here. If you have questions about this recall, contact Woodside Acquisitions Inc. at woodsideinc.pa@gmail.com or call 814-218-2804.
