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Public Health Recall : Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) by Woodside Acquisitions:

 Monmouth County Health Department
LINCS Communication
(Local Information Network and Communication System)
__________________________________________________________________

  

Subject: Public Health Recall : 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

Date: 05/18/2022 09:15:31

Official Message No.: 111334-5-18-2022-RECL

Contact Info: Eric Lieberman | 6098264935 | This email address is being protected from spambots. You need JavaScript enabled to view it.

William Manley | 6098264935 | This email address is being protected from spambots. You need JavaScript enabled to view it.

Attachments: No

 

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.

 

Health care professionals and patients 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 FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

 

Read Recall :  https://www.fda.gov/medical-devices/medical-device-recalls/woodside-acquisitions-inc-recalls-oral-rapid-sars-cov-2-antigen-rapid-test-kits-and-joysbio-sars-cov?utm_medium=email&utm_source=govdelivery

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