CLARISSE Test midstream IRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00808829125672), received between Jul 22, 2025 and Jul 22, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Defective Device; Activation, Positioning or Separation Problem; Defective Device; Activation, Positioning or Separation Problem

  I'VE USED DOLLAR TREE PREGNANCY TESTS ON AND OFF FOR ABOUT 3 YEARS AND NEVER HAD ANY ISSUES UNTIL NOW. RECENTLY, I BOUGHT ONE AND IT COMPLETELY FAILED LIKE NO CONTROL LINE, TOTALLY UNUSABLE. FIGURED IT MIGHT'VE BEEN A DUD, SO I WENT BACK AND GRABBED ANOTHER. SAME THING HAPPENED AGAIN. I DECIDED TO CALL THE NUMBER ON THE PACKAGE (WWW.DELTABRANDS.COM) TO REPORT IT, JUST TO LET THEM KNOW. THE GUY WHO ANSWERED WAS SUPER DISMISSIVE RIGHT FROM THE START AND SAID, "DIDN'T YOU CALL YESTERDAY?". I EXPLAINED THE SITUATION AND MENTIONED THE SECOND TEST ALSO DIDN'T WORK. HE TOLD ME I "SHOULDN'T BE BUYING MORE" AND LITERALLY HUNG UP ON ME. IT WAS SO UNPROFESSIONAL AND HONESTLY MADE ME FEEL STUPID FOR EVEN BOTHERING TO REACH OUT. I'M NOT ABOUT TO WALK INTO DOLLAR TREE WITH A USED TEST IN HAND JUST TO PROVE A POINT, BUT I'VE RELIED ON THESE FOR YEARS BECAUSE THEY WERE ALWAYS AFFORDABLE AND ACCURATE. WITH HOW HARD IT IS TO GET A DOCTOR'S APPOINTMENT QUICKLY, THESE TESTS HAVE BEEN A GO-TO FOR ME. I'M CURRENTLY KEEPING A CLOSE EYE ON THINGS AND GETTING BLOOD DRAWN AT (B)(6) JUST TO BE SAFE, BUT IT REALLY SUCKS TO FEEL DISMISSED WHEN YOU'RE JUST TRYING TO TAKE CARE OF YOUR HEALTH. I?VE ALREADY CONTAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563505 ↗
• MalfunctionJul 22, 2025Defective Device; Activation, Positioning or Separation Problem; Defective Device; Activation, Positioning or Separation Problem

  I HAVE USED DOLLAR TREE PREGNANCY TESTS ON AND OFF FOR ABOUT 3 YEARS AND NEVER HAD ANY ISSUES UNTIL NOW. RECENTLY I BOUGHT ONE AND IT COMPLETELY FAILED LIKE NO CONTROL LINE, TOTALLY UNUSABLE. FIGURED IT MIGHT HAVE BEEN A DUD, SO I WENT BACK AND GRABBED ANOTHER. SAME THING HAPPENED AGAIN. I DECIDED TO CALL THE NUMBER ON THE PACKAGE (WWW.DELTABRANDS.COM)TO REPORT IT, JUST TO LET THEM KNOW. THE GUY WHO ANSWERED WAS SUPER DISMISSIVE RIGHT FROM THE START AND SAID,"DID NOT YOU CALL YESTERDAY?''. I EXPLAINED THE SITUATION AND MENTIONED THE SECOND TEST ALSO DID NOT WORK. HE TOLD ME "SHOULD NOT BE BUYING MORE " AND LITERALLY HUNG UP ONE ME. IT WAS SO UNPROFESSIONAL AND HONESTLY MADE ME FEEL STUPID FOR EVEN BOTHERING TO REACH OUT . I AM NOT ABOUT TO WALK INTO DOLLAR TREE WITH A USED TEST IN HAND JUST TO PROVE A POINT , BUT I HAVE RELIED ONE THESE FOR YEARS BECAUSE THEY WERE ALWAYS AFFORDABLE AND ACCURATE . WITH HOW HARD IT IS TO GET A DOCTOR'S APPOINTMENT QUICKLY, THESE TESTS HAVE BEEN A GO-TO FOR ME. I AM CURRENTLY KEEPING A CLOSE EYE ON THINGS AND GETTING BLOOD DRAWN AT (B)(6) JUST TO BE SAFE, BUT IT REALLY SUCKS TO FEEL DISMISSED WHEN YOU ARE JUST TRYING TO TAKE CARE OF YOUR HEALTH. I HAV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563469 ↗