FDAClass IIOctober 19, 2022

COVID Test Kit Nonsterile recall

COVID Test Kit Nonsterile

Why was COVID Test Kit Nonsterile recalled?

Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.

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?

1) UDI-DI: Product Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2) UDI-DI: Product Code: AHCV18B, Lots 868221 (exp. 05/31/2023), 842221 (exp. 05/31/2023)

Product
COVID Test Kit Nonsterile
Recalling firm
American Contract Systems, Inc.
Quantity
39,575 kits
Distribution
Distribution to one customer in PA only
Recall date
October 19, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls