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U.S. Department of Health and Human Services

Class 1 Device Recall Oral Rapid SARSCoV2 Antigen Rapid Test Kit

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 Class 1 Device Recall Oral Rapid SARSCoV2 Antigen Rapid Test Kitsee related information
Date Initiated by FirmApril 09, 2022
Create DateMay 12, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1044-2022
Recall Event ID 89995
Product Classification Coronavirus antigen detection test system. - Product Code QKP
ProductOral 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 ContactCustomer 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 2
No Marketing Application
ActionOn 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 Commerce34,240 units
DistributionUS distributions to states of: AL and GA.
Total Product Life CycleTPLC 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.
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