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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:

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