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
Anonymous (not verified)
Mon, 05/16/2022 – 13:16
Detailed Description
Woodside Acquisitions Inc. recalls COVID-19 Rapid Test Kits because they are not authorized, cleared, or approved by the FDA.
Center
Center for Devices and Radiological Health
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)
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 Woodside Acquisitions Inc 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.
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. 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.
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:
Medical Device Recall Database Entry: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit
Medical Device Recall Database Entry: Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
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.
Short Title
Woodside Acquisitions Inc. Recalls Unauthorized COVID-19 Rapid Test Ki
Source Organization
FDA
Short Description
Woodside Acquisitions Inc. recalls COVID-19 Rapid Test Kits because they are not authorized, cleared, or approved by the FDA.
Content Owner
Center for Devices and Radiological Health
Publish Date
Mon, 05/16/2022 – 13:45
Review Date
Tue, 05/16/2023 – 00:00
Last Reviewed Date
Mon, 05/16/2022 – 00:00
Site Structure
Medical Device Recalls
Next Review Date
1 Year
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Medical Devices
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English
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