Recall Z-1044-2022— Woodside Acquisitions Inc.

Name: FDA recall Z-1044-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-09

Class I · Ongoing

Class I FDA medical device recall by Woodside Acquisitions Inc., initiated 2022-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test. Reason: Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States..

Recalling firm: Woodside Acquisitions Inc.
Classification: Class I
Status: Ongoing
Initiated: 2022-04-09
Firm location: tyrone, PA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.