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  5. 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
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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

June 9, 2022, Update: The FDA updated this recall classification notice to remove Woodside Acquisitions Inc from the device use section of the notice. 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)
  • Product Codes: See recall database entry
  • Distribution Dates: January 6, 2022, to January 20, 2022
  • Devices Recalled in the U.S.: 51,240
  • Date Initiated by Firm: April 9, 2022

Device Use

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.

Reason for Recall

Woodside Acquisitions Inc. is recalling these tests because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. As these tests were not authorized, cleared, or approved by FDA, there is not sufficient data demonstrating that the test’s performance is accurate. This means 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 Inc. has received no complaints or reports of injuries, deaths, or adverse events.

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.

Customers were asked to verify receipt and understanding of this recall letter by emailing Woodside Acquisitions Inc at woodsideinc.pa@gmail.com.

Contact Information

Customers with questions about this recall should contact Woodside Acquisitions Inc. at woodsideinc.pa@gmail.com or call 814-218-2804.

Additional Resources:

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices, including suspected false results or injuries from self-swabbed nasopharyngeal or oropharyngeal samples, to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

 
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