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

SEOUL,South Korea,May 5,2023 -- 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 atgo.roche.com/pilottestor by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1.

Reference image: This lot number in the image doesn’t indicate the affected lot numbers.

List of affected lot numbers

Lot Number

53K38N1T1

53K38N2T1

53K38N3T1

53K38N4T1

53K38N5T1

53K38P1T1

53K38P2T1

53K38P3T1

53K41T5T1

53K41X1T1

53K41X2T1

53K41X3T1

53K4211T1

53K4212T1

53K4213T1

53K4221T1

53K4222T1

53K4223T1

53K4224T1

53K4225T1

53K4231T1

53K4232T1

53K4233T1

53K4261T1

53K4262T1

53K4271T1

53K4272T1

53K4273T1

53K4274T1

53K4291T1

53K4292T1

53K42A1T1

53K42A2T1

53K42A3T1

53K42E1T1

53K42G1T1

53K42G2T1

53K42H1T1

53K42H2T1

53K42L1T1

53K42L2T1

53K4361AC

53K4362AC

53K4392AC

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.

References

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.