BEUDAMED
    FDA Recall Terminated

    Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 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-2391-2012 · Initiated August 3, 2012

    Recall

    Recall Number
    Z-2391-2012
    Event Number
    62894
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    GKP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 3, 2012
    Posted
    September 14, 2012
    Terminated
    October 2, 2015
    Address
    180 Hartwell Road, Bedford, MA, 01730-2443

    Description

    Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 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

    Action

    The firm, Instrumentation Laboratory, sent a "Mandatory Test Parameter Upgrade" letter dated June 7, 2012 with upgrade kits P-14.8 via USPS on August 3 thru August 10 to US and Canadian customers and notified International Affiliates via e-mail on August 2, 2012. The customers were ask to complete and return the Mandatory Test Parameter Upgrade Tracking Form via fax: 781-861-4207 or email: [email protected]. If you have any questions, call 781-861-4204.

    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

    2171 units