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
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- Product Type:
- Medical Devices
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Recall Reason DescriptionDue to microbial contamination in the liquid buffer solution.
- Company Name:
- SD Biosensor, Inc.
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- Product Description:
Product DescriptionCOVID-19 At-Home Test
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/pilottest or by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1.
The Pilot COVID-19 At-Home Test is an over-the-counter rapid antigen test and uses a nasal swab sample that can be self-collected and self-tested by individuals ages 14 years and older, and by an adult for children ages 2 to 13 years old.
Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with the contaminated liquid during opening the tube or handling of the open tube or while performing the test.
This request to discontinue use and dispose of the affected tests is currently isolated to specific lots of the Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, exclusively in the U.S. Roche-branded rapid antigen tests authorized in markets outside of the U.S. are unaffected.
You may report adverse events such as unexpected side effects or injury or product quality problems to the U.S. Food and Drug Administration's (FDA's) MedWatch Adverse Event Reporting program in the following ways:
- Online: Complete and submit a report on this FDA webpage.
- Standard mail or fax: Download this form or call 1-800-332-1088 to request a form. Then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
For more information, please view MedWatch Online Voluntary Reporting Form (fda.gov). This action is being taken with the knowledge of the FDA.
This product has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in-vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
SOURCE SD Biosensor
Company Contact Information
- Roche Customer Support Center