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POTENTIAL SOURCES
OF ERROR
Interference with
urine specimen
testing due to
presence of
blood
Use of expired
strips
Failure of device
calibration
Page 24
Clarity Platinum Urine Analyzer
OPERATOR'S MANUAL
VALIDATION RESULTS
Results are flagged when blood analyte has a high
concentration block, which can create false positive
readings for other reagent pads. The failure alert
mechanism is employed to notify the user by
flagging the test result with the warning message,
'Possible false positive results due to blood
interference may occur for glucose, protein, bilirubin,
urobilinogen, nitrite, leukocytes, ketones.' The
message is displayed on screen, printed on the
test results, and included in the data packet which
is sent electronically (if applicable).
The product barcode feature will alert the user with
a 'Barcode Error' message generated due to expired
strip bottles. The system will lock out and will not
allow users to perform tests until a new barcode
is scanned.
The Clarity Platinum Urine Analyzer performs a
hardware check for mechanical, electrical, and
optical components when the device is switched
ON. The user is alerted with an 'Optical System Fail'
error message if there is damage to the white
calibration block and/or gradual buildup of urine
sediment.
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