FDA Safety Communication - Magellan Diagnostics' LeadCare Testing Systems Use with Venous Blood

PUBLISHED: May 17, 2017
Relevant to: Ambulatory Care, Clinical Lab, Hospitals, Medical Office/Clinic

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are warning that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.

The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. The FDA and CDC are conducting studies to identify the cause and better characterize the extent of the problem. At this time, the FDA has no evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples.

The FDA is aggressively investigating the root cause of this issue with the manufacturers, health care facilities, and the CDC. The FDA will update its safety communications as critical information becomes available.

BACKGROUND:

Magellan Diagnostics Inc. manufactures the following lead testing systems affected by this warning:

  • LeadCare
  • LeadCare II
  • LeadCare Plus
  • LeadCare Ultra.

The LeadCare Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a vein (venous). This warning applies to all four Magellan Diagnostics LeadCare Testing Systems when processing venous blood samples, in the United States.

Note: Magellan’s LeadCare II is a point-of-care (CLIA-waived) blood lead testing system on which users mostly test capillary blood samples. However, some laboratories also process venous blood samples with the LeadCare II system, which is why this safety communication includes all Magellan LeadCare Testing Systems.

The LeadCare Testing Systems are used in clinical laboratories, doctor’s offices, clinics, and hospitals throughout the U.S.

RECOMMENDATIONS:

The FDA recommends laboratories and health care professionals take the following actions:

  • Discontinue using Magellan’s LeadCare 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 FDA 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.

The CDC recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Please see the complete FDA Safety Communication by following the link provided below.

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