Description of Event or Problem · 1
I RECENTLY HAD A LUMIRADX SARSCOV2 AG TEST PERFORMED AT (B)(6). THE TEST CAME BACK POSITIVE. I SUBSEQUENTLY HAD TWO SARS-COV-2, NAA PCR (PIXEL - (B)(6)) TESTS PERFORMED ON DIFFERENT DAYS ((B)(6)) WHICH GAVE A NEGATIVE RESULT. ADDITIONALLY, I HAD A RT-PCR TEST (ABBOTT LABS ID NOW) PERFORMED ON (B)(6) 2021 WHICH IS STILL PENDING. I BELIEVE THE POSITIVE GIVEN BY LUMIRADX WAS LIKELY A FALSE POSITIVE. I SAW THERE WAS A FDA CLASS 2 MEDICAL DEVICE RECALL RECENTLY ISSUED FOR DEFECTIVE TEST STRIPS, BUT THE LISTED LOT NUMBERS WERE NOT THE LOT NUMBER MY TEST CAME FROM. MY LOT NUMBER WAS: 6,000,174 WITH EXPIRATION OF 6/9/2021. MY WIFE ALSO HAD ALL OF THE SAME TESTS PERFORMED ON THE SAME DAYS AND HAD ALL OF THE SAME RESULTS. HER RESULTS WERE AS FOLLOWS: (B)(6) 2021 - LUMIRADX SARSCOV2 AG TEST - POSITIVE (LOT NUMBER WAS: 6,000,174 WITH EXPIRATION OF 6/9/2021) (B)(6) 2021 - SARS-COV-2, NAA PCR (PIXEL - (B)(6)) - NEGATIVE (B)(6) 2021 - SARS-COV-2, NAA PCR (PIXEL - (B)(6)) - NEGATIVE (B)(6) 2021 - RT-PCR TEST (ABBOTT LABS ID NOW) - NEGATIVE. FDA SAFETY REPORT ID # (B)(4).