Class 1 Device Recall Pilot COVID19 AtHome Test

• Date Initiated by Firm: March 31, 2023
• Date Posted: May 23, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1594-2023
• Recall Event ID: 92137
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
• Code Information: Lot Numbers: 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 53K38N3T1 53K38N2T1 53K38N1T1 53K38N4T1 53K38N5T1 53K38P1T1 53K38P2T1 53K38P3T1
• Recalling Firm/ Manufacturer: SD Biosensor, Inc.; 1556 Beon-Gil, Yeongtong; C4th & 5th Floor Digital Empire Bldg, 16, Deogyeong-Daero; Suwon Korea (the Republic of)
• For Additional Information Contact: go.roche.com/pilottest; 1-866-987-6243
• Manufacturer Reason for Recall: The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
• FDA Determined Cause: Material/Component Contamination
• Action: Press release issued 5/4/23 by SD BioSensor: https://www.prnewswire.com/news-releases/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-301816494.html A notification letter titled "Subject: Statement about the patient risk assessment for the Extraction buffer of Pilot" COVID-19 At-Home Test" dated 3/31/23 was sent to Roche. A Roche URGENT MEDICAL DEVICE REMOVAL notification letter dated 5/4/23 was sent to customers. . Assess your current inventory, quarantine, and discontinue distribution of all affected PilotTM COVID-19 At-Home Test kits, and Roche will contact you in the near future to discuss final actions related to the affected product in your inventory. . If you distributed product to consumers, make information in the enclosed Pilot COVID-19 At-Home Test Consumer Message (TP-01837) available to your consumers per your established process for recall notification. . Complete all sections of the enclosed Recall Response form (TP-01836) and return it according to the instructions on the form. . Maintain this Urgent Medical Device Removal (UMDR) for future reference. In addition to this communication to U.S. distributors, as part of a media release on May 03, 2023, consumers are being asked to stop using and discard affected test kits, and contact Roche directly for follow-up actions. Questions Product images, lot information, and consumer actions are available at go.roche.com/pilottest or by contacting the Roche Support Network Customer Support Center at 1-866-987-6243 and select option 1.
• Quantity in Commerce: 2,712,767 kits
• Distribution: US Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.