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Magellan LeadCare II - Interpreting the Control Test Results; How Magellan Diagnostics Assigns Lead Level Ranges

Magellan LeadCare II
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LeadCare
®
II User's Guide 3-5
Interpreting the Control Test Results
The target values are printed on the control vials. The blood lead level that
appears on the LeadCare II Analyzer should be within the acceptable range
provided for that control. If the reported value is within the acceptable limits for
both the Level 1 and Level 2 controls, your LeadCare II System is operating
properly. You may now test patient samples.
If the reported value for the Level 1 and/or Level 2 control is outside the
acceptable range, refer to the troubleshooting section of the LeadCare II User’s
Guide. If, after following the instructions, the control value is still out of range
please contact LeadCare Product Support at 1-800-275-0102.
CAUTION: Do NOT proceed to patient samples unless both
the Level 1 and Level 2 control results are within the
acceptable ranges.
How Magellan Diagnostics Assigns Lead Level Ranges
Acceptable ranges for each lot and lead level are established by Magellan
Diagnostics using LeadCare II Blood Lead Testing Systems. Magellan
Diagnostics establishes these ranges using extensive replicate analyses and
rigid quality control.

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