Reuters logo
BRIEF-U.S. FDA releases statement from Alberto Gutierrez on status of FDA’s investigation into inaccurate results from certain lead tests‍​
July 13, 2017 / 3:25 PM / 2 months ago

BRIEF-U.S. FDA releases statement from Alberto Gutierrez on status of FDA’s investigation into inaccurate results from certain lead tests‍​

July 13 (Reuters) - U.S. FDA:

* Statement from Alberto Gutierrez on status of FDA’s investigation into inaccurate results from certain lead tests‍​

* Says as part of investigation, we inspected Magellan Diagnostics’ facility in North Billerica, Massachusetts

* Says design validation for Magellan Diagnostics’ leadcare test systems did not ensure device conforms to defined user needs and intended uses‍​

* Report regarding leadcare test systems device correction, removal actions was not sent to FDA within 10 days of initiating correction or removal

* Says the design change implemented by Magellan Diagnostics to increase incubation time is inadequate

* MDR report was not submitted within 30 days of receiving information that suggests that marketed device has malfunctioned

* Reviewing evidence from Magellan Diagnostics’ facility inspection to determine if there have been violations of federal law Source text (bit.ly/2uVW6gu) Further company coverage:

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below