BEUDAMED
    FDA Recall Open, Classified

    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

    Recall: Z-1594-2023 · Initiated March 31, 2023

    Recall

    Recall Number
    Z-1594-2023
    Event Number
    92137
    Firm
    SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire
    FEI Number
    3012133212
    Product Code
    QKP
    Status
    Open, Classified
    Root Cause
    Material/Component Contamination
    Initiated
    March 31, 2023
    Posted
    May 23, 2023
    Address
    Bldg 16, Deogyeong-Daero Suwon Korea (the Republic, of)

    Description

    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

    Reason

    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.

    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.

    Distribution

    US Nationwide.

    Quantity

    2,712,767 kits