This malfunction may potentially impact staining performance.No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.Patient identifier, age or date of birth, patient sex, weight, ethnicity, and race: patient information has not been provided by the user.
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The (b)(6) customer reported staining alteration.The customer application specialist found that the stopcock was not attached well and was leaking slightly, this might have caused problems with the dispensation hence the results.The problem was solved.The samples can be repeated and continue with diagnostics.The instrument is fully operational, within specification, and ready for the user.Diagnostics were not altered.No harm or patient impact was indicated.
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