October 23, 2017 / 6:09 PM / in a year

BRIEF-U.S. FDA issues warning letter to Magellan Diagnostics

Oct 23 (Reuters) - ‍U.S. Food and Drug Administration :

* ‍U.S. Food and Drug Administration says issued a warning letter to Magellan Diagnostics Inc​

* ‍U.S. FDA - Magellan diagnostics has until Nov. 10, to notify FDA about specific steps co has taken to address violations, to prevent them from recurring​

* U.S. FDA says in letter that Magellan marketed significantly modified versions of two of its blood lead testing systems without FDA's required approval​

* ‍U.S. FDA - Inspection showed Magellan altered two of its blood lead testing systems after they were already FDA cleared

* ‍U.S. FDA - During inspection investigators observed violations, including failing to submit medical device reports regarding discrepancies in test results​ Source text for Eikon: Further company coverage:

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