BEUDAMED
    FDA Recall Terminated

    i-STAT EC4+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.

    Recall: Z-1797-2010 · Initiated February 5, 2010

    Recall

    Recall Number
    Z-1797-2010
    Event Number
    54652
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    JPI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 5, 2010
    Posted
    June 11, 2010
    Terminated
    July 25, 2012
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT EC4+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.

    Reason

    Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

    Action

    The firm, Abbott Point of Care, sent an "Urgent Field Safety Notice Product Recall" letter dated January 2010 to the customers. Safety Alert /Product Recall letters were also sent by Federal Express commencing on February 5, 2010. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to replace the i-STAT Hematocrit/HCT and Calculated Hemoglobin/HB /Cartridge and Test Information (CT) Sheet found in their i-STAT System manual with those included in the mailing , and to provide a copy of the letter another facility, if they have forwarded any cartridges. If you should have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020 or your Abbott Point of Care representative.

    Distribution

    Worldwide distribution: USA and Argentina; Austria; Bahamas; Bolivia; Brazil; Chile; Hong Kong; China; China; Columbia; Costa Rica; Denmark; Dominican Republic; Ecuador; El Salvador; Finland; Georgia; Greece; Honduras; India; India; Ireland; Israel; Italy; Japan; Kuwait; Mauritius; Mexico; Norway; Oman; Panama; Paraguay; Peru; Poland; Portugal; Qatar; Russian Federation; Saudi Arabia; Singapore; South Africa; South Korea; Spain; Switzerland; Taiwan; Thailand; Trinidad and Tobago; Turkey; United Arab Emirates; Uruguay; Yemen; Netherlands Antilles; Venezuela; Australia; Belgium; France; Germany; Italy; New Zealand; Spain; Sweden; and The Netherlands.

    Quantity

    40,446 total cartridges, all varieties