FDA Recall
Open, Classified
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Recall: Z-1044-2022
·
Initiated April 9, 2022
Recall
- Recall Number
- Z-1044-2022
- Event Number
- 89995
- Firm
- Woodside Acquisitions Inc.
- FEI Number
- 3022253625
- Product Code
- QKP
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- April 9, 2022
- Address
- 1625 Lincoln Ave., tyrone, PA, 16686
Description
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.
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.
Distribution
US distributions to states of: AL and GA.
Quantity
34,240 units