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News From the Food and Drug Administration
May 1, 2018

Progress in Lead Test Investigation

JAMA. 2018;319(17):1758. doi:10.1001/jama.2018.4938

Rubber stoppers in certain blood collection tubes have been implicated in an FDA investigation of inaccurate results from blood lead tests manufactured by Magellan Diagnostics of Billerica, Massachusetts. Becton, Dickinson and Company (BD) of Franklin Lakes, New Jersey, produces the collection tubes.

The FDA issued an initial warning last year that Magellan lead tests used with venous blood may provide results that are lower than the actual lead level in the blood. The warning included all 4 of Magellan’s lead tests. However, the FDA noted that the tests were acceptable for use with blood from finger or heel sticks.