MedWatch - The FDA Safety Information and Adverse Event Reporting Program
LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results
- Discontinue using Magellan’s’ LeadCare System Testing Systems with venous blood samples. At this time, all LeadCare systems can be used with capillary blood samples.
- If laboratories or health care professionals are concerned about using the LeadCare Test Systems, the alternative options are mass spectrometry or atomic absorption methods. These are not point-of-care tests, and may be available only from larger-capacity laboratories such as reference labs.
- This Safety Communication replaces all previous communication from Magellan Diagnostics on their LeadCare lead testing systems including Magellan’s most recent Field Safety Correction Notification dated April 28, 2017.
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- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.