BEUDAMED
    FDA Enforcement Class II Terminated

    HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems

    Recall: Z-0514-2019 · Reported December 5, 2018

    Enforcement

    Recall Number
    Z-0514-2019
    Event ID
    81475
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EUROTROL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 5, 2018
    Initiation Date
    October 18, 2018
    Classification Date
    November 28, 2018
    Termination Date
    January 7, 2020
    Address
    850 N Black Branch Rd, N/A, Elizabethtown, KY, 42701, United States

    Description

    HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems

    Reason

    Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

    Code Info

    Lot Number: 81166

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: Austria, Australia, Bahrain, France, Hong Kong, Indonesia, Ireland, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Maldives, New Zealand, Mozambique, Pakistan, Poland, Slovenia, Africa, Spain, Thailand, Finland, Norway, and UK.

    Quantity

    2000