The FDA updated this recall classification notice to remove Woodside Acquisitions Inc from the device use section of the notice, according to a news release.
This firm’s name does not appear on the label for the Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) and to clarify that these tests were not authorized, cleared, or approved by FDA and there is not sufficient data demonstrating that test’s performance is accurate. This means 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 or death.
Recalled product:
- Product Names: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
- The Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) which use patient samples to detect proteins, called antigens, found on the SARS-CoV-2 virus. The samples are collected using a nasal swab.
Who may be affected:
- People who may have been tested for SARS-CoV-2 using the Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit or the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
- Health care providers and other organizations who used the Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit or the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
- Distributors of the Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit or the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
What to do:
On April 9, 2022, Woodside Acquisitions Inc. 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 Inc.
- If the tests were distributed to third parties, perform a recall from all purchasers.
