The United States Food and Drug Administration (FDA) has issued a statement on findings from ongoing investigation into lead testing issues and an updated medical device safety alert concerning LeadCare Testing Systems, manufactured by Magellan Diagnostics.
The FDA has conducted investigations with Magellan Diagnostics as well as Becton Dickinson (BD), the manufacturer of blood sample collection tubes used alongside with the lead tests, to determine the cause of the inaccurate lead test results from the LeadCare Testing Systems.
The FDA concluded that there was a significant chance of false results with Magellan's LeadCare tests when used with whole blood collected from the vein and stored in certain BD tubes. Upon further investigations, BD determined that the affected tubes' rubber stoppers contain a chemical called thiuram that can release sulfur-containing gases that dissolve into blood samples and bind tightly to lead particles. This chemical reaction makes it difficult for the Magellan lead tests to detect the correct amount of lead in a sample.
The FDA recommends laboratories and health care professionals take the following actions:
For details, please refer to the FDA website:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm602343.htm
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558988.htm
For information of our previous Important Safety Alert, please refer to MDCO website: http://www.mdco.gov.hk/english/safety/recalls/recalls_20170518.html
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 March 2018