TOPIC: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) by Woodside Acquisitions: Class I Recall - Due to Distribution to U.S. Customers without Authorization, Clearance, or Approval from the FDA
AUDIENCE: Patient, Health Professional
ISSUE: Woodside Acquisitions is recalling these tests because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. Woodside Acquisitions 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.
If you use the affected product, this may cause serious adverse health consequences or death.
Woodside Acquisitions has received no complaints or reports of injuries, deaths, or adverse events.
For more information about this recall, click on the red button Read Recall below.
BACKGROUND: The Woodside Acquisitions Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) use patient samples to detect proteins, called antigens, found on the SARS-CoV-2 virus. The samples are collected using a nasal swab.
RECOMMENDATIONS: On April 9, 2022, Woodside Acquisitions sent a Medical Device Recall letter to customers, distributors, and other U.S. consignees requesting them to take the following actions:
- Immediately return all unused product to Woodside Acquisitions.
- If the tests were distributed to third parties, perform a recall from all purchasers.
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