Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning LeadCare Testing Systems, manufactured by Magellan Diagnostics.

The FDA is warning facilities such as laboratories or health clinics that Magellan Diagnostics' LeadCare Testing Systems may underestimate blood lead levels (BLLs) and give inaccurate results when processing venous blood samples. The FDA is providing recommendations to help mitigate the risk of inaccurate test results to assure that patients receive accurate information regarding potential lead exposure. The FDA is also strongly urging parents and at-risk adults to speak with their health care provider about the U.S. Centers for Disease Control's (CDC) recommendations on re-testing. 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.

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

• 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.
• Report any adverse events to the FDA and to Magellan Diagnostics.
• 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.

For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558988.htm
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm558733.htm
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm558769.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 18 May 2017