COMPANY ANNOUNCEMENT
Recall Notice - SD Biosensor, Inc. Requests Discontinuation of Use and Disposal of Specific Pilot™ COVID-19 At-Home Tests in the United States Due to Microbial Contamination in the Liquid Buffer Solution
ummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
- Company Name:
- SD Biosensor, Inc.
- Brand Name:
- Product Description:
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.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall-notice-sd-biosensor-inc-requests-discontinuation-use-and-disposal-specific-pilottm-covid-19
エフ・ホフマン・ラ・ロシュ（F. Hoffmann-La Roche, Ltd.）は、スイスのバーゼルに本拠を置く世界的な製薬・ヘルスケア企業である[2]。スイス証券取引所上場企業（SIX: ROG）。
F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the fifth-largest pharmaceutical company in the world by revenue[5] and the leading provider of cancer treatments globally.[6][7]
The company controls the American biotechnology company Genentech, which is a wholly owned affiliate, and the Japanese biotechnology company Chugai Pharmaceuticals, as well as the United States-based companies Ventana and Foundation Medicine. Roche's revenues during fiscal year 2020, were 58.32 billion Swiss francs. Descendants of the founding Hoffmann and Oeri families own slightly over half of the bearer shares with voting rights (a pool of family shareholders 45%, and Maja Oeri a further 5% apart), with Swiss pharma firm Novartis owning a further third of its shares until 2021. Roche is one of the few companies increasing their dividend every year, for 2020 as the 34th consecutive year.
F. Hoffmann-La Roche is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).[8]
Founded in 1896 by Fritz Hoffmann-La Roche, the company was early on known for producing various vitamin preparations and derivatives.[9] In 1934, it became the first company to mass-produce synthetic vitamin C, under the brand name Redoxon. During the Second World War, Roche collaborated with the Nazi regime in Germany and used forced labour in its German and Polish-based factories.[10] They also moved all their Jewish employees to the United States to save them from Nazi attention.[11]
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