BEUDAMED
    FDA Recall Terminated

    i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).

    Recall: Z-2171-2012 · Initiated February 1, 2012

    Recall

    Recall Number
    Z-2171-2012
    Event Number
    62533
    Firm
    Abbott Point Of Care Inc.
    FEI Number
    2245578
    Product Code
    MYT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 1, 2012
    Posted
    August 9, 2012
    Terminated
    February 8, 2013
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).

    Reason

    The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

    Action

    Abbott Point of Care (APOC) sent an URGENT RECALL NOTICE dated February 2012 to all affected customers via e-mail and also contacted by phone. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that if their facility was performing testing at more than approximately 7500 feet above sea level, they should have an alternate test method available should they experience an issue. If they have forwarded any cartridges to another facility, they should provide a copy of the Urgent Recall Notice to them. For questions customers were instructed to call 800-366-8020, Option 1 or contact their Abbott Point of Care representative. For questions regarding this recall call 609-454-9000.

    Distribution

    Worldwide Distribution - USA including AZ and CO and internationally to Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Ireland, Italy, Korea, Kuwait, Mauritius, Mexico, Netherland (Antilles), Nigeria, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, R.O.C., Thailand, UAE, United Kingdom, and Yemen.

    Quantity

    368,149 cartridges US; 32,725 OUS