- Becton, Dickinson & Company, at the FDA's request, has identified the source of false results from lead tests performed on whole blood samples collected in Vacutainer tubes on equipment made by Meridian Bioscience (VIVO) unit Magellan Diagnostics.
- The culprit appears to be a chemical called thiuram which is used to make certain rubber stoppers placed in the tubes after the blood is collected. Thiuram releases gases that contain sulfur which dissolve in blood samples and tightly bind to lead particles. The chemical reaction interferes with the ability of Magellan's test to accurately measure the amount of lead.
- The FDA maintains its recommendation not to use Magellan's lead tests with venous blood samples. Tests performed on finger/heel-stick samples (capillary samples) are unaffected.
- Previously: Meridian unit Magellan in hot water with FDA over lead test results (July 13, 2017)
- Previously: Becton, Dickinson gets Warning Letter after FDA inspection of New Jersey facility (Jan. 11)
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Original article