PlainRecalls
FDA Devices Critical Class I Ongoing

Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test

Reported: May 18, 2022 Initiated: April 9, 2022 #Z-1044-2022

Product Description

Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test

Reason for Recall

Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

Details

Units Affected
34,240 units
Distribution
US distributions to states of: AL and GA.
Location
tyrone, PA

Frequently Asked Questions

What product was recalled?
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test. Recalled by Woodside Acquisitions Inc.. Units affected: 34,240 units.
Why was this product recalled?
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 18, 2022. Severity: Critical. Recall number: Z-1044-2022.