Z-1044-2022Class I

Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test

Name: Z-1044-2022 Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Creator: Woodside Acquisitions Inc.
Published: 2022-04-09
License: https://open.fda.gov/license/

Woodside Acquisitions Inc. / initiated 2022-04-09 / Open, Classified

FDA source

Woodside Acquisitions Inc. began a recall of Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test on 2022-04-09. FDA classified it as Class I and gives the reason as "Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1044-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-04-09
Posted: 2022-05-12
Recalling firm: Woodside Acquisitions Inc.
Product: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
FDA 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 in commerce: 34,240 units
Distribution: US distributions to states of: AL and GA.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1044-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1044-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12
Z-1045-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-12

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)