Magellan LeadCare II - Precautions

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• The LeadCare II Blood Lead Analyzer is a CLIA-waived device. Facilities that
perform tests with the LeadCare II System must have a CLIA Certicate of
Waiver as issued under the authority of the Public Health Service Act (PHSA)
(42 U.S.C. 263(a). In addition to a waiver certicate, laboratories performing this
test must comply with all applicable state and local laws.
• Any modications by the laboratory to the test system or the manufacturer’s
instructions will result in the test no longer meeting the requirements of the
waived category.
• All laboratories eligible for a CLIA Certicate of Waiver must follow the manu-
facturer's instructions as specied in the LeadCare II User's Guide, LeadCare II
Quick Reference Guide and LeadCare II Test Kit Package Insert.
• Observe universal precautions for handling blood samples as dened by the
U.S. Public Health Service, Centers for Disease Control. Refer to the LeadCare II
User's Guide for information about where to nd this document.
• The LeadCare treatment reagent contains dilute hydrochloric acid solution
which may cause eye, skin, and respiratory system irritation. In case of acci-
dental contact immediately ush skin and eyes with running water for up to 15
minutes and move to fresh air. Seek medical assistance in situations where eye
contact; skin irritation or burn; or difculty breathing occurs.
• Do NOT mix components from different lots of test kits.
• Test kit components (kit box, sensors, controls, and treatment reagent tubes)
are labeled with expiration dates. Using any item with an expired date may
produce inaccurate results. Do not use any component with an expiration date
that has passed. Check the expiration on the kit box as this is the earliest date.
• Proper sample preparation is essential for accurate results. Take precautions to
ensure that the sample collection area is not contaminated by environmental
sources of lead. Refer to Collecting and Handling Blood Lead Samples—2004
published by the Department of Health and Human Services, Centers for
Disease Control.
• Use only fresh, whole blood. Mix the blood with treatment reagent within 24
hours of collection. Follow sample collection instructions exactly.
Wear protective gloves,
safety glasses and lab
coats.
Dispose of materials in
appropriate biohazard
containers.
Allow analyzer, test kit
and samples to reach
room temperature
before testing.
Precautions
Precautions
Caution
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