Recall Z-1044-2022 ยท QKP Coronavirus Antigen Detection Test System.
Woodside Acquisitions Inc.
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
| Date | Apr 9, 2022 |
| Status | Open, Classified |
| Reason | Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States. |
| Root 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 | 34,240 units |
| Distribution | US distributions to states of: AL and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.