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Failure in sterlity -Class II device

  • 1.  Failure in sterlity -Class II device

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jan-2018 10:03
    This message was posted by a user wishing to remain anonymous

    ​Hi,

    If a manufacturer of Class II sterile device  has one unit failing in sterility from the total samples charged , also some units from this lot have already been distributed. What should be the next steps?The gamma sterilization and sterility testing is contracted.

    Thanks,