BEUDAMED
    FDA Recall Terminated

    Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942

    Recall: Z-0576-06 · Initiated January 27, 2006

    Recall

    Recall Number
    Z-0576-06
    Event Number
    34522
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 27, 2006
    Posted
    February 28, 2006
    Terminated
    October 19, 2006
    Address
    200 Prospect St, Waltham, MA, 02453-3457

    Description

    Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942

    Reason

    Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs

    Action

    Nova Biomedical Issued on 1/27/2006 an Advisory Notice to Stat Profile CCX Customers to report the malfunction and request the Good Laboratory Practices (GLP) be used and review be made to assure the calibration status and QC is being performed. A new software version is scheduled to be released to correct the error.

    Distribution

    Nationwide Foreign: Canada, UAE, Taiwan, Singapore, Budapest, UK, France, Malaysia, France, Mexico, Korea, Finland, Germany, Turkey, Ireland, Italy, Austria, Australia, Netherlands, Venezuela, Japan, Greece, Thailand, Israel, Spain, China, Hong Kong, Argentina, Czech Republic, Croatia,Trinidad WI

    Quantity

    498 units