Flowflex COVID-19 Antigen Home Test L031-118B5, L031-125M5, L031-125N5, L031-125P5Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00682607002306), received between Jan 25, 2022 and Dec 19, 2023 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023

  TESTED USING A COVID-19 ANTIGEN TEST FROM ACON LABORATORIES, INC., SAN DIEGO, CA 92121. THE TEST GAVE A FALSE NEGATIVE AS COMPARED TO A SECOND ANTIGEN TEST. I AM STRONGLY POSITIVE BY BINAX NOW AND PCR TEST.

  Patient problems: Viral Infection

  MAUDE report 18364543 ↗
• MalfunctionAug 22, 2023

  MULTIPLE FALSE NEGATIVE TESTS FROM SAME MANUFACTURER THAT I THINK POSES A HEALTH RISK AS THERE MAY BE PEOPLE THINKING THEY ARE COVID FREE BUT INFECTING OTHERS. I HAD MY FIRST SYMPTOMS ON MONDAY (B)(6) AND TOOK A TEST THAT DAY AROUND 2 PM. MY SYMPTOMS PROGRESSED THAT DAY AND GOT WORSE AND I TOOK A TEST AROUND 9:00 AM ON (B)(6) 2023. I CALLED MY DOCTOR AND EXPLAINED MY SYMPTOMS AND THEY "SCHEDULED" ME FOR A VISIT AT URGENT CARE SO I COULD TAKE A FLU TEST. I WAS SEEN BY A DOCTOR AROUND 9:00 PM AND FLU TEST WAS NEGATIVE. AFTER LISTENING TO MY SYMPTOMS HE TESTED ME AND COMMENTED I WAS THE SECOND PERSON THAT DAY THAT TESTED POSITIVE AFTER TESTING NEGATIVE WITH AN AT HOME TEST. HE THOUGHT IT WAS POSSIBLE I HAD TESTED TOO EARLY. ON WEDNESDAY (B)(6) 2023, I TOOK ANOTHER TEST AROUND 9:00 AM TO SEE IF IT WOULD TEST POSITIVE TO KNOW IF I COULD TRUST IT IF I TESTED NEGATIVE. I THEN PURCHASED NEW TESTS ONLINE FROM MY LOCAL CVS AND MY DAUGHTER PICKED IT UP AND I TOOK ANOTHER TEST WITH THE NEW CVS TEST AT 1:30 ON (B)(6) AND IT WAS NEGATIVE. AT THIS POINT ALL TESTS ARE FLOW FLEX. I THEN FOUND ANOTHER TEST THE SCHOOL HAD SENT FROM INTELLISWAB THAT HASN'T EXPIRED AT 1:50 ON (B)(6) AND WITHIN A FEW MI

  Patient problems: Viral Infection

  MAUDE report 17602904 ↗
• MalfunctionAug 22, 2023

  MULTIPLE FALSE NEGATIVE TESTS FROM SAME MANUFACTURER THAT I THINK POSES A HEALTH RISK AS THERE MAY BE PEOPLE THINKING THEY ARE COVID FREE BUT INFECTING OTHERS. I HAD MY FIRST SYMPTOMS ON MONDAY (B)(6) AND TOOK A TEST THAT DAY AROUND 2 PM. MY SYMPTOMS PROGRESSED THAT DAY AND GOT WORSE AND I TOOK A TEST AROUND 9:00 AM ON (B)(6) 2023. I CALLED MY DOCTOR AND EXPLAINED MY SYMPTOMS AND THEY "SCHEDULED" ME FOR A VISIT AT URGENT CARE SO I COULD TAKE A FLU TEST. I WAS SEEN BY A DOCTOR AROUND 9:00 PM AND FLU TEST WAS NEGATIVE. AFTER LISTENING TO MY SYMPTOMS HE TESTED ME AND COMMENTED I WAS THE SECOND PERSON THAT DAY THAT TESTED POSITIVE AFTER TESTING NEGATIVE WITH AN AT HOME TEST. HE THOUGHT IT WAS POSSIBLE I HAD TESTED TOO EARLY. ON WEDNESDAY (B)(6) 2023, I TOOK ANOTHER TEST AROUND 9:00 AM TO SEE IF IT WOULD TEST POSITIVE TO KNOW IF I COULD TRUST IT IF I TESTED NEGATIVE. I THEN PURCHASED NEW TESTS ONLINE FROM MY LOCAL CVS AND MY DAUGHTER PICKED IT UP AND I TOOK ANOTHER TEST WITH THE NEW CVS TEST AT 1:30 ON (B)(6) AND IT WAS NEGATIVE. AT THIS POINT ALL TESTS ARE FLOW FLEX. I THEN FOUND ANOTHER TEST THE SCHOOL HAD SENT FROM INTELLISWAB THAT HASN'T EXPIRED AT 1:50 ON (B)(6) AND WITHIN A FEW MI

  Patient problems: Viral Infection

  MAUDE report 17602870 ↗
• MalfunctionAug 22, 2023

  MULTIPLE FALSE NEGATIVE TESTS FROM SAME MANUFACTURER THAT I THINK POSES A HEALTH RISK AS THERE MAY BE PEOPLE THINKING THEY ARE COVID FREE BUT INFECTING OTHERS. I HAD MY FIRST SYMPTOMS ON MONDAY (B)(6) AND TOOK A TEST THAT DAY AROUND 2 PM. MY SYMPTOMS PROGRESSED THAT DAY AND GOT WORSE AND I TOOK A TEST AROUND 9:00 AM ON (B)(6) 2023. I CALLED MY DOCTOR AND EXPLAINED MY SYMPTOMS AND THEY "SCHEDULED" ME FOR A VISIT AT URGENT CARE SO I COULD TAKE A FLU TEST. I WAS SEEN BY A DOCTOR AROUND 9:00 PM AND FLU TEST WAS NEGATIVE. AFTER LISTENING TO MY SYMPTOMS HE TESTED ME AND COMMENTED I WAS THE SECOND PERSON THAT DAY THAT TESTED POSITIVE AFTER TESTING NEGATIVE WITH AN AT HOME TEST. HE THOUGHT IT WAS POSSIBLE I HAD TESTED TOO EARLY. ON WEDNESDAY (B)(6) 2023, I TOOK ANOTHER TEST AROUND 9:00 AM TO SEE IF IT WOULD TEST POSITIVE TO KNOW IF I COULD TRUST IT IF I TESTED NEGATIVE. I THEN PURCHASED NEW TESTS ONLINE FROM MY LOCAL CVS AND MY DAUGHTER PICKED IT UP AND I TOOK ANOTHER TEST WITH THE NEW CVS TEST AT 1:30 ON (B)(6) AND IT WAS NEGATIVE. AT THIS POINT ALL TESTS ARE FLOW FLEX. I THEN FOUND ANOTHER TEST THE SCHOOL HAD SENT FROM INTELLISWAB THAT HASN'T EXPIRED AT 1:50 ON (B)(6) AND WITHIN A FEW MI

  Patient problems: Viral Infection

  MAUDE report 17602817 ↗
• MalfunctionMay 10, 2023Device Markings/Labelling Problem

  FLOWFLEX COVID 19 ANTIGEN BEING SOLD AT CVS IN (B)(6) NEAR (B)(6) HAS TWO EXPIRY DATES PRINTED. THE ONE OUTSIDE SAYS EXPIRY AT THE END OF 2023 BUT THE POUCH INSIDE SAYS IT EXPIRED IN MARCH OF 2023. THIS IS DECEPTIVE LABELLING BY THE MANUFACTURER AND WILL GIVE FALSE NEGATIVE RESULTS AS A RESULT.

  Patient problems: Insufficient Information

  MAUDE report 16910930 ↗
• MalfunctionFeb 10, 2023False Positive Result; Nonstandard Device

  I BELIEVE FALSE POSITIVES ARE OCCURING WITH THE FLOWFLEX ANTIGEN TEST. LOT:# COV1110226, EXP 11-28-2022 . THESE WERE PROVIDED TO ME BY MY PLACE OF EMPLOYMENT, MINNEAPOLIS PUBLIC SCHOOLS. I FIRST TESTED POSITIVE WITH THEM (B)(6) 2022, HAD MINIMAL SYMPTOMS (SLIGHT RUNNY NOSE, BUT I HAD JUST TRAVELED BY AIR ACROSS THE COUNTRY SO EASILY COULD'VE BEEN POLLEN, USING N95 ON PLANE FOR 5 HOURS, ETC). I REALLY BECAME SUSPICIOUS WHEN I ONCE AGAIN TESTED POSITIVE A MONTH LATER, SAME BATCH OF TESTS ON (B)(6) 2023. I FOLLOWED IT IMMEDIATELY WITH A BINAX TEST WHICH WAS NEGATIVE. I REPEATED ON MONDAY: FLOWFLEX WAS POSITIVE; BINAX WAS NEGATIVE. I THEN WENT FOR A PCR(POLYMERASE CHAIN REACTION) ON MONDAY (B)(6) 2023, WHICH JUST CAME BACK WITH NEGATIVE RESULTS. I DON'T KNOW HOW TO EXPLAIN IT OTHER THAN THE FLOWFLEX ARE FALSE POSITIVES. I AM A SCHOOL NURSE AND THESE ARE THE TESTS WE GIVE OUT TO FAMILIES. IF THESE TESTS ARE BAD, WE NEED TO KNOW. I'VE TRIED TO RESEARCH IF THIS IS HAPPENING WITH OTHER FLOWFLEX TESTS, BUT ONLY HAVE SEEN THE RECALL OF THE DARK BLUE BOX, WHICH THIS IS NOT.

  Patient problems: Insufficient Information

  MAUDE report 16363159 ↗
• MalfunctionNov 9, 2022False Positive Result

  HELLO. I HAVE EXPERIENCED A FALSE POSITIVE COVID TEST RESULT WHEN USING THE FLOWFLEX COVID-19 ANTIGEN HOME TEST WHITE BOX VERSION (NOT THE RECALLED ONE BLUE BOX VERSION). THE LOT # FOR THE TESTS I USED WAS COV2020181 / EXP 2023-06-24. I DO NOT HAVE SYMPTOMS BUT WAS WORRIED ABOUT POSSIBLE EXPOSURE AFTER A LONG FLIGHT. I TRIED 3 OF THOSE TESTS AND THEY ALL SHOWED A VERY FAINT LINE INDICATING I HAVE COVID. I TRIED A DIFFERENT AT-HOME TEST (NOT FLOWFLEX) AND THAT ONE WAS NEGATIVE. I HAVE ALSO GONE TO CVS FOR A LAB PCR (POLYMERASE CHAIN REACTION) TEST WHICH HAS ALSO COME BACK NEGATIVE. IT APPEARS THERE IS AN ISSUE WITH THE FLOWFLEX COVID-19 ANTIGEN HOME TEST GIVING FALSE POSITIVE RESULTS. THANKS. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771145 ↗
• MalfunctionNov 7, 2022Manufacturing, Packaging or Shipping Problem

  I BOUGHT TWO FLOWFLEX COVID19 TESTS FROM A PHARMACY IN (B)(6) TODAY. I OPENED THE FIRST TEST AND DISCOVERED THAT THE EXTRACTION BUFFER TUBE WAS EMPTY AND HAD NO SEAL ON IT. IT DID NOT APPEAR TO HAVE BEEN TAMPERED WITH; IT JUST LOOKED LIKE AN EMPTY TUBE WAS INCLUDED WITH THE TEST. I OPENED THE SECOND TEST AND EVERYTHING WAS CORRECT, INCLUDING THE EXTRACTION BUFFER TUBE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753621 ↗
• InjurySep 7, 2022False Negative Result

  I WOKE UP NOT FEELING WELL AND IMMEDIATELY WENT TO MY PHARMACY AND PURCHASED 3 COVID19 ANTIGEN TEST. FLOWFLEX WAS MY ONLY OPTION. I RETURNED HOME, THOROUGHLY READ THE DIRECTIONS AND BEGAN THE TEST. AS SOON AS THE SWAB ENTERED THE APPROPRIATE AREA OF MY NASAL CAVITY THERE WAS AN IMMEDIATE INTENSE BURNING SENSATION THAT MADE ME FEEL AS IF I HAD JUST PUT CHEMICALS UP MY NOSE. MY EYE ON THE SAME SIDE BEGAN TO UNCONTROLLABLY TEAR AND WATER. I SWABBED FOR THE COMPLETE TIME AND REMOVED THE SWAB. IT WAS IN SO MUCH PAIN I'M NOT QUITE SURE HOW I FORCED MYSELF TO INSERT THE SWAB INTO MY OTHER NOSTRIL. I DID AND THE SAME EXCRUCIATING PAIN OCCURRED, ONCE AGAIN FEELING AS IF I WAS RUBBING A CHEMICAL IN MY NOSE. SAME TEARING AND WATERING FROM MY OTHER EYE. I FOLLOWED THE REMAINDER OF THE INSTRUCTIONS AND COMPLETED THE TEST. I READ MY RESULTS AFTER 15 MINUTES, 20 MINUTES, 25 MINUTES, AND 30 MINUTES - NEGATIVE. A NEGATIVE RESULT WAS A BIT OF A RELIEF BUT I STILL KNEW SOMETHING WAS GOING ON BY THE WAY I WAS FEELING. NOW, IN ADDITION TO NOT FEELING WELL, I HAD A BURNING SENSATION IN EACH NOSTRIL WITH BOTH SIDES FEELING SWOLLEN. SINCE MY ONE AND ONLY EXPERIENCE WITH TESTING FOR COVID (PRIOR TO THIS TI

  Patient problems: Burning Sensation; Erythema; Fever; Pain; Swelling/ Edema

  MAUDE report 15379878 ↗
• MalfunctionAug 8, 2022False Positive Result

  I HAD COVID SYMPTOMS, AS DID MY WHOLE FAMILY. PREVIOUS TESTS WERE NEGATIVE BUT WE TESTED AGAIN, BECAUSE WE WERE ON DAYS 3 AND 4 SO APPROACHING THE TIME LIMIT FOR PAXLOVID. I GOT A FAINT POSITIVE FLOWFLEX TEST (IN WHITE PACKAGING), SO I TESTED AGAIN. I GOT A FAINT POSITIVE AGAIN. EVERYONE ELSE IN MY FAMILY TESTED NEGATIVE DESPITE MY KID BEING SICKER THAN ME. BECAUSE MY SISTER HAD TWO FALSE POSITIVES WITH THE SAME KIND OF TEST TWO WEEKS AGO, I WAS SUSPICIOUS. I USED A BINAX TEST, WHICH CAME UP NEGATIVE. I ALSO SCHEDULED A TEST TO TREAT APPOINTMENT TO CONFIRM, AND GET PAXLOVID IF I WAS POSITIVE BECAUSE I'M HIGH RISK. THE HEALTHCARE PROVIDER DID A PCR TEST, WHICH WAS NEGATIVE. IT APPEARS BOTH FLOWFLEX TESTS WERE FALSE POSITIVES. TWO FAINT POSITIVES, THAT WERE FALSE POSITIVES. MODEL/CATALOG/UDI NUMBER: UNSURE, SEE LABEL PICTURE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15192118 ↗
• MalfunctionJun 23, 2022Product Quality Problem; Therapeutic or Diagnostic Output Failure

  THE DROPPER TOP OF THE SQUEEZE TUBE THAT IS USED TO APPLY THE SPECIMEN DIRECTLY TO THE TEST CARTRIDGE, MALFUNCTIONED. INSTEAD OF THE SPECIMEN DRIPPING OUT OF THE DROPPER INTO THE SPECIMEN WINDOW EASILY, THE SPECIMEN FLUIDS STARTED BUBBLING OUT OF THE SIDES WHERE THE PLUG PART OF THE LID IS SUPPOSED TO FIT SECURELY INTO THE TUBE. THE DROPPER HOLE MUST NOT HAVE BEEN OPENED DURING MANUFACTURING PROCESS AND IT CAUSED A MESS OF MY FLUIDS AND THE MIXTURE TO GO ALL OVER, AND NOTHING INTO THE WINDOW. HOME TEST DONE. DOESN'T HAVE HIGH OR LOW RANGES. MALFUNCTION OF THE TEST MAY HAVE NOT ALLOWED ENOUGH SPECIMEN INTO THE CONTROL WINDOW TO PRODUCE ACCURATE RESULTS. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800807 ↗
• MalfunctionApr 29, 2022False Positive Result

  FLOWFLEX RAPID COVID TEST APPEARS TO HAVE PROVIDED MULTIPLE FALSE POSITIVES. TESTED MY SON (AGE (B)(6), MADE SURE TO FOLLOW THE DIRECTIONS CAREFULLY AND GET A GOOD SAMPLE) MULTIPLE TIMES. USED THE SAME BRAND ON MYSELF, HUSBAND, AND OTHER SON AND GOT NEGATIVES. FOLLOWED WITH CARESTART BRAND ANTIGEN TEST (NEGATIVE), (B)(6) STATE PROJECT BEACON PCR TEST (NEGATIVE), (B)(6) VANGUARD IN (B)(6) RAPID TEST (NEGATIVE), AND A (B)(6)VANGUARD IN (B)(6), PCR TEST (NEGATIVE). REF L031-118B5, LOT COV1120041, (EXPIRES 2022-12-01) MADE IN (B)(6); L031319-01, NUMBERS NEXT TO QR CODE: (01)00682607660261 (17)221201 (10)COV1120041, BAR CODE: 682607660261. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14257478 ↗
• MalfunctionApr 7, 2022Patient Device Interaction Problem

  I USED A FLOWFLEX COVID-19 AT-HOME ANTIGEN TEST AND RECEIVED SUSPICIOUS RESULTS: ON (B)(6) 2022 AT 9AM DID THE TEST PER PACKAGE DIRECTIONS, EXCEPT ALSO SWABBED THROAT PER GUIDANCE FROM RESEARCH, AND RECEIVED A WEAK POSITIVE RESULT. 3 HOURS LATER I PERFORMED A SUPERVISED NAAT TEST AT UNIVERSITY OF WASHINGTON (NO THROAT SWAB, PER SUPERVISED PROCEDURE), RECEIVED A NEGATIVE TEST RESULT. ON (B)(6) 2022 AT 9AM, DID ANOTHER RAPID ANTIGEN TEST FROM ANOTHER MANUFACTURER (SAME PROCEDURE DEVIATION ABOVE), RECEIVED A NEGATIVE RESULT. ON (B)(6) 2022 AT 9AM, DID ANOTHER FLOWFLEX RAPID ANTIGEN TEST (SAME LOT, SAME PROCEDURE) AND RECEIVED AGAIN A WEAK POSITIVE RESULT. ON (B)(6) 2022 I HAD NASAL CONGESTION. NASAL CONGESTION RESOLVED BETWEEN THE NAAT TEST ON (B)(6) 2022 AND RAT TEST ON (B)(6) 2022. NO COVID-SPECIFIC SYMPTOMS APPEARED AS THEY DID DURING MY PREVIOUS COVID INFECTION (COUGH, LUNG CAPACITY REDUCTION, DIFFICULTY EXERCISING). FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052173 ↗
• MalfunctionJan 25, 2022False Positive Result

  HAD TO TAKE UNPAID TIME OFF; FALSE POSITIVE TEST RESULTS. AT HOME TEST CAME BACK POSITIVE BUT PCR TEST CAME BACK NEGATIVE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13358198 ↗