BEUDAMED
    FDA Enforcement Class II Terminated

    Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

    Recall: Z-2388-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2388-2012
    Event ID
    62894
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumentation Laboratory Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    August 3, 2012
    Classification Date
    September 14, 2012
    Termination Date
    October 2, 2015
    Address
    180 Hartwell Road, Bedford, MA, 01730-2443, United States

    Description

    Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

    Reason

    Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

    Code Info

    Serial Number range: 09080100 through12060403 Distributed between: Aug 2009 to Jun 2012

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.

    Quantity

    304 units