BEUDAMED
    FDA Enforcement Class II Ongoing

    HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602

    Recall: Z-0150-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0150-2022
    Event ID
    88627
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Instrumentation Laboratory
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 27, 2021
    Initiation Date
    August 25, 2021
    Classification Date
    October 19, 2021
    Address
    180 Hartwell Rd, N/A, Bedford, MA, 01730-2443, United States

    Description

    HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602

    Reason

    Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

    Code Info

    All currently released lots and future lots

    Distribution

    US Nationwide Foreign: Canada Armenia Austria Australia Belgium Brunei Brazil Belarus Switzerland China Colombia Czech Republic Germany Denmark Spain Finland France United Kingdom Gibraltar Greece Hong Kong Hungary Indonesia Ireland Israel India Iran Italy¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ Japan South Korea Kuwait Kazakhstan Lebanon Sri Lanka Lithuania Luxembourg Macau Mexico Malaysia Netherlands Poland Portugal Qatar Reunion Romania Serbia Russia Saudi Arabia Sweden Thailand Tunisia Turkey Taiwan Vietnam Zambia

    Quantity

    25,738 US