FDA Medical Device Recalls (openFDA)
Woodside Acquisitions Inc.: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
- Recall number
- Z-1044-2022
- Recalling firm
- Woodside Acquisitions Inc.
- Product
- Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
- Status
- Open, Classified
- Initiated
- 2022-04-09
- Posted
- not on file
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3022253625
- Firm city
- tyrone
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28