FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation
By Michael Mezher -
Published 12 January 2018
After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May, the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes.
Categories: News, FDA, In vitro diagnostics, Medical Devices
Tags: BD, LeadCare, Magellan Diagnostics, Vacutainer, Warning Letter