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05-05-2023 08:39 PM - edited 05-05-2023 08:47 PM
BELOW IS QUOTED FROM THE FDA WEB PAGE FOR THIS RECALL:
"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"
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