BEUDAMED
    FDA Recall Terminated

    i-STAT Level 2 Control Value Assignment Sheets Human Consumption

    Recall: Z-1020-2011 · Initiated August 3, 2010

    Recall

    Recall Number
    Z-1020-2011
    Event Number
    56392
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 3, 2010
    Posted
    February 2, 2011
    Terminated
    September 28, 2011
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT Level 2 Control Value Assignment Sheets Human Consumption

    Reason

    Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types.

    Action

    Abbott Point of Care Inc., sent an URGENT RECALL NOTICE to all affected customers on 8/3/2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to replace all copies of the value sheets with the ones provided in the letter. ASLO, if they have a disc with the Value sheets on it, it is to be replaced with the updated disc and the original discarded. If the control materials, discs or value sheets have been forwarded to another facility, a copy of the letter was to be sent to them. The Business Reply card is to be completed and returned to Abbott. Questions or comments are to be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1.

    Distribution

    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of Argentina, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, El Salvador, France, Georgia Republic, Germany, Hong Kong, Israel, Italy, Kuwait, Mexico, Netherlands, New Zealand, Panama, Paraquay, Peru, Poland, South Africa, Sweden, Switzerland, Taiwan, Turkey, UAE, UK, Uruquay, and Yemen.

    Quantity

    8293 Value sheets worldwide