FDAClass IMay 18, 2022

Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit recall

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

Why was Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit recalled?

Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots

Product
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Recalling firm
Woodside Acquisitions Inc.
Quantity
34,240 units
Distribution
US distributions to states of: AL and GA.
Recall date
May 18, 2022
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls