FDAClass IJuly 13, 2022

Nasopharyngeal sample collection tray for COVID-19 recall

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

Why was Nasopharyngeal sample collection tray for COVID-19 recalled?

Affected products were assembled off-site by individuals who may not have been properly trained.

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?

UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221

Product
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Recalling firm
American Contract Systems, Inc.
Quantity
274,400 kits total
Distribution
US distribution in the state of Minnesota.
Recall date
July 13, 2022
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls