May 31, 2017: Are you aware of the FDA warning about lead testing?

The following is a press release that is going to be sent out regarding lead testing:

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results.  This is the manufacturer of the test kits utilized at Vanderbilt, and this FDA recall affects lead tests that were conducted at Vanderbilt. The FDA’s warning is based on currently available data that indicate Magellan lead tests, when performed on blood drawn from a vein, may provide results that are lower than the actual level of lead in the blood.  Currently, the FDA believes the issue may date back to 2014.  The FDA has no evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples.  However, the CDC recommends that healthcare professionals retest children younger than six years (72 months) of age at the time of the alert (May 17, 2017) if their test result was <10 ug/dL.  The CDC also recommends that women, who are currently pregnant or nursing and were tested while pregnant or nursing, get retested.  Since this notification, Vanderbilt is sending all lead testing the ARUP Reference Laboratories for testing by an alternate method (ICP/MS) that is not affected by this recall.  ARUP accepts the same preferred specimen types as Vanderbilt [lavender cap EDTA microtainer tubes (0.5 mL whole blood) for pediatric capillary samples or royal blue metal free (7 mL whole blood EDTA) or Lavender Vacutainer 5 mL whole blood EDTA tubes as an alternate for adult and venous collections).  The test is performed daily at ARUP, so the turnaround times should be the similar to that provided at Vanderbilt (next day to following day).  We regret any inconvenience this provides to our patients and will continue to update healthcare professionals as we receive notice from the manufacturer, Magellan, and the FDA. Please contact Laboratory Client Services at 5-LABS (615-875-5227) with any questions.

Submitted by Jennifer Colby, PhD, Associate Director of Clinical Chemistry, VUMC


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Donna Seger, MD

Medical Director

Tennessee Poison Center

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