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Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection System

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DATE NOTIFICATION INITIATED:

    February 25, 2005

PRODUCT

    Automated Blood Cell Separator, Haemonetics LN8150 Mobile Collection System, MCS+ 9000
    Model Number: LN 08150-110-E
    Serial Numbers: 05A047-05A048, 05A050, 05A064-05A072, 05A092-05A100, 05B017-05B023

MANUFACTURER:

    Haemonetics Corp
    Braintree, MA

REASON:

    Haemonetics has discovered a manufacturing error on the MCS+ LN8150 CPU board that could affect display performance and result in inability to initiate a procedure or premature termination of a procedure. The problem would manifest itself in a display failure upon start-up or cause display failure intermittently during a procedure. The display would simply go blank.

    A Haemonetics Field Service Engineer will contact consignees to replace the CPU boards in the devices referenced above. In the meantime, Haemonetics recommends not to use the devices until the circuit boards have been replaced.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

Updated March 24, 2005
 
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