DISCONTINUED: COVID-19 At-Home Tests 　

Emergency Message System

May 8th, 2023

Some COVID-19 At-Home Tests recalled

Summary

Company Announcement Date: May 04, 2023

FDA Publish Date: May 05, 2023

Product Type: Medical Devices

Reason for Announcement:

Due to microbial contamination in the liquid buffer solution.

Company Name: SD Biosensor, Inc.Brand Name: Pilot

Product Description: COVID-19 At-Home Test

Company Announcement:

SEOUL, South Korea, May 4, 2023 /PRNewswire/ -- SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits).

The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.

Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness.

To date, no such illness has been reported. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water and if irritation persists, seek medical attention.

The affected test kits were distributed by Roche Diagnostics to distributors and retailers in the U.S. Product images, lot information and follow-up actions are available at go.roche.com/pilottestExternal Link Disclaimer or by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1.