FDAClass IIJanuary 11, 2023

Detect Covid-19 Test Product/Model Number: 21205 recall

Detect Covid-19 Test Product/Model Number: 21205

Why was Detect Covid-19 Test Product/Model Number: 21205 recalled?

There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.

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?

HY263, HY264, and HB264 Expiration 01JAN2023

Product
Detect Covid-19 Test Product/Model Number: 21205
Recalling firm
Detect Headquarters
Quantity
10142 (US); 960 OUS
Distribution
Domestic distribution nationwide. Foreign distribution to Hong Kong.
Recall date
January 11, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls