Magellan LeadCare II - Preface; Other LeadCare II Documents; Troubleshooting

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Preface
NOTE:
The LeadCare
®
II Blood Lead Analyzer is a CLIA-waived
device. Facilities that perform tests with the LeadCare II
system must have a CLIA Certificate of Waiver (COW) or
higher, as issued under the authority of the Public Health
Service Act (PHSA) (42 U.S.C. 263(a)). In addition to a
Certificate of Waiver, all laboratories performing this test
must comply with all applicable state and local laws.
All laboratories eligible for a CLIA Certificate of Waiver
must follow the manufacturer's instructions as specified in
the LeadCare II User's Guide (this guide), LeadCare II Quick
Reference Guide and in the LeadCare II Package Insert.
Other LeadCare II Documents
• LeadCare II Quick Reference Guide (English)
• LeadCare II Test Kit Package Insert
• LeadCare II Flash Drive
Troubleshooting
Troubleshooting procedures are described in detail in Chapter 5
of this guide. Read this section carefully. If you continue to
experience problems with device operation, contact Magellan
Diagnostics Product Support at 1-800-275-0102 or
LeadCareSupport@magellandx.com.