Class 1 Device Recall Oral Rapid SARSCoV2 Antigen Rapid Test Kit

• Date Initiated by Firm: April 09, 2022
• Create Date: May 12, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1044-2022
• Recall Event ID: 89995
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
• Code Information: All lots
• Recalling Firm/ Manufacturer: Woodside Acquisitions Inc.; 1625 Lincoln Ave.; tyrone PA 16686
• For Additional Information Contact: Customer Service; 814-218-2804
• Manufacturer Reason for Recall: Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
• FDA Determined Cause: No Marketing Application
• Action: On April 9, 2022, the firm notified affected distributors via email with subject line "IMPORTANT!!! Recall Notice". The attached recall letter instructed distributors to immediately return all unused product to the recalling firm for a refund. If distributors have further distributed the product, they should forward the recall information to all affected customer accounts. The firm may be reached Monday through Friday, 9:00 AM to 4:30 PM, Eastern Time at 814-218-2804.
• Quantity in Commerce: 34,240 units
• Distribution: US distributions to states of: AL and GA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.