BEUDAMED
    FDA Enforcement Class II Completed

    microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059

    Recall: Z-1349-2024 · Reported March 27, 2024

    Enforcement

    Recall Number
    Z-1349-2024
    Event ID
    94043
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Landauer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 27, 2024
    Initiation Date
    February 8, 2024
    Classification Date
    March 21, 2024
    Address
    2 Science Rd, Glenwood, IL, 60425-1531, United States

    Description

    microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059

    Reason

    Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications.

    Code Info

    All Lot/Serial Numbers:

    Distribution

    Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Brazil, Canada, China, France, India, Japan, Jordan, Malaysia, Mexico, Pakistan, Peru, Philippines, Rep of Korea, Singapore, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, Viet Nam.

    Quantity

    975 units