May 14, 2020 / 11:56 PM / 22 days ago

BRIEF-FDA Says Abbott's ID Now Point-Of-Care Test To Diagnose COVID-19 May Return False Negative Results

May 14 (Reuters) - U.S. Food and Drug Administration:

* CORONAVIRUS (COVID-19) UPDATE: FDA INFORMS PUBLIC ABOUT POSSIBLE ACCURACY CONCERNS WITH ABBOTT ID NOW POINT-OF-CARE TEST

* FDA SAYS ABBOTT ID NOW POINT-OF-CARE TEST TO DIAGNOSE COVID-19 MAY RETURN FALSE NEGATIVE RESULTS

* U.S. FDA- ALERTING PUBLIC TO EARLY DATA THAT SUGGEST POTENTIAL INACCURATE RESULTS FROM USING ABBOTT ID NOW POINT-OF-CARE TEST TO DIAGNOSE COVID-19

* U.S. FDA - ABBOTT’S TEST CAN STILL BE USED AND CAN CORRECTLY IDENTIFY MANY POSITIVE CASES IN MINUTES

* FDA - RECEIVED 15 ADVERSE EVENT REPORTS ABOUT ABBOTT ID NOW DEVICE THAT SUGGEST SOME USERS ARE RECEIVING INACCURATE NEGATIVE RESULTS

* U.S. FDA- ABBOTT HAS AGREED TO CONDUCT POST-MARKET STUDIES FOR ID NOW DEVICE THAT EACH WILL INCLUDE AT LEAST 150 COVID-19 POSITIVE PATIENTS

* FDA- AGENCY IS REVIEWING ADVERSE EVENT REPORTS ABOUT ABBOTT ID NOW DEVICE Source text for Eikon:

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