FDAClass IMay 11, 2022

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit recall

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Why was Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit recalled?

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

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: UL-AG-2110-05-Q UL-AG-2111-02-Q UL-AG-2112-01-Q UL-AG-2112-02-Q UL-AG-2201-03-Q

Product
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Recalling firm
SML Distribution, LLC
Quantity
209,450 units
Distribution
US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.
Recall date
May 11, 2022
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls