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U.S. Department of Health and Human Services

Class 1 Device Recall Joysbio SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold)

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  Class 1 Device Recall Joysbio SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold) see related information
Date Initiated by Firm April 09, 2022
Create Date May 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1045-2022
Recall Event ID 89995
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Code Information All lots
Recalling Firm/
Woodside Acquisitions Inc.
1625 Lincoln Ave.
tyrone PA 16686
For Additional Information Contact Customer Service
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 2
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 17,000 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.