Recall Z-1045-2022
Woodside Acquisitions Inc. · initiated April 9, 2022
Class I – dangerous or defective products that could cause serious health problems or death
Product
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Codes / lots: All lots
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 taken
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.
Details
- Recall number
- Z-1045-2022
- Initiated
- April 9, 2022
- Product code
- QKP – Coronavirus Antigen Detection Test System.
- Quantity
- 17,000 units
- Distribution
- US distributions to states of: AL and GA.
- Recalling firm
- Woodside Acquisitions Inc., tyrone, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1044-2022 Class I | Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 TestFirm distributed tests which have not been cleared or authorized for marketing or distribution in the United… | 04/09/2022Open, Classified |