BinaxNOW® G6PD 780-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10811877010705), received between Dec 17, 2019 and Oct 27, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FOUR (4) FALSE NEGATIVE RESULTS WITH THE BINAXNOW G6PD KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF FOUR (4). CONFIRMATION ELISA TESTING WAS PERFORMED ON AN UNKNOWN DATE, WHICH GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED THRICE ON THE SAME SAMPLE AND ONCE ON A NEW SAMPLE AT AN INTERVAL OF 2 WEEKS, WHICH EACH GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THERE WAS AN IMPACT IN THE PATIENT'S TREATMENT; A DRUG CONTRAINDICATED FOR G6PD DEFICIENCY WAS PRESCRIBED AND TAKEN. THE NAME OF THE DRUG WAS NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS DEATH OR NO SERIOUS INJURY BASED ON THE TEST RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18024538 ↗
• MalfunctionOct 27, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FOUR (4) FALSE NEGATIVE RESULTS WITH THE BINAXNOW G6PD KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FOUR (4). CONFIRMATION ELISA TESTING WAS PERFORMED ON AN UNKNOWN DATE, WHICH GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED THRICE ON THE SAME SAMPLE AND ONCE ON A NEW SAMPLE AT AN INTERVAL OF 2 WEEKS, WHICH EACH GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THERE WAS AN IMPACT IN THE PATIENT'S TREATMENT; A DRUG CONTRAINDICATED FOR G6PD DEFICIENCY WAS PRESCRIBED AND TAKEN. THE NAME OF THE DRUG WAS NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS DEATH OR NO SERIOUS INJURY BASED ON THE TEST RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18024531 ↗
• MalfunctionOct 27, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FOUR (4) FALSE NEGATIVE RESULTS WITH THE BINAXNOW G6PD KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF FOUR (4). CONFIRMATION ELISA TESTING WAS PERFORMED ON AN UNKNOWN DATE, WHICH GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED THRICE ON THE SAME SAMPLE AND ONCE ON A NEW SAMPLE AT AN INTERVAL OF 2 WEEKS, WHICH EACH GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THERE WAS AN IMPACT IN THE PATIENT'S TREATMENT; A DRUG CONTRAINDICATED FOR G6PD DEFICIENCY WAS PRESCRIBED AND TAKEN. THE NAME OF THE DRUG WAS NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS DEATH OR NO SERIOUS INJURY BASED ON THE TEST RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18024455 ↗
• MalfunctionOct 27, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FOUR (4) FALSE NEGATIVE RESULTS WITH THE BINAXNOW G6PD KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF FOUR (4). CONFIRMATION ELISA TESTING WAS PERFORMED ON AN UNKNOWN DATE, WHICH GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED THRICE ON THE SAME SAMPLE AND ONCE ON A NEW SAMPLE AT AN INTERVAL OF 2 WEEKS, WHICH EACH GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THERE WAS AN IMPACT IN THE PATIENT'S TREATMENT; A DRUG CONTRAINDICATED FOR G6PD DEFICIENCY WAS PRESCRIBED AND TAKEN. THE NAME OF THE DRUG WAS NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS DEATH OR NO SERIOUS INJURY BASED ON THE TEST RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18024439 ↗
• InjuryOct 26, 2021Non Reproducible Results; Non Reproducible Results

  THE USER REPORTED MULTIPLE DISCREPANCY RESULTS WERE FOUND IN SEVERAL CASES WHEN PERFORMING THE BINAXNOW G6PD KIT. THE CUSTOMER REPORTED THERE WAS ABOUT 7-8 CASES, THE FIRST RESULT SHOWED G6BP DEFFICIENT WHILE THE SECOND REPEAT TESTING SHOWED NORMAL. THE CUSTOMER REPORTED THAT THEY ALSO CONFIRMED RESULTS WITH A PARALLED RUN WITH QUANTITATIVE G6PD TEST USING A NEW BOX KIT AND TURN OUT ALL THE CASES WERE FOUND TO BE NORMAL. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701784 ↗
• InjuryJul 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED A FALSE NORMAL RESULT ON A KNOWN DEFICIENT PATIENT WITH THE BINAXNOW G6PD TEST. THE CUSTOMER REPORTED PREVIOUS TESTING ((B)(6) 2020) WAS REPORTED AS DEFICIENT WITH THE BINAXNOW G6PD TEST, CONFIRMED DEFICIENT BY SPECTROPHOTOMETRY BY THE (B)(6) CLINIC. THE PATIENT WAS REPORTED TO HAVE A HEMATOCRIT OF 31.9% AND WHITE BLOOD CELL COUNT OF 3,600 AT THE TIME OF THE (B)(6) 2020 TESTING. TESTING PERFORMED ON (B)(6) 2020 (EDTA WHOLE BLOOD COLLECTED (B)(6) 2020) GENERATED NORMAL RESULTS WITH THE BINAXNOW G6PD TEST. REPEAT TESTING WITH THE SAME SAMPLE, ON THE SAME KIT LOT, PERFORMED BY A DIFFERENT OPERATOR ALSO GENERATED NORMAL RESULTS ON THE BINAXNOW G6PD TEST. CONFIRMATION TESTING BY SPECTROPHOTOMETRY BY THE (B)(6) CLINIC WAS DEFICIENT. THE PATIENT WAS REPORTED TO HAVE A HEMATOCRIT OF 26.5% AND WHITE BLOOD CELL COUNT OF 22,900. THE CUSTOMER STATED THE PATIENT HAS CANCER (NOT OTHERWISE SPECIFIED) AND SICKLE CELL TRAIT, AND HAD BEEN ADMINISTERED WBC GROWTH STIMULATOR A FEW DAYS PRIOR TO THE (B)(6) 2020 TESTING. ATTEMPTS TO GAIN FURTHER INFORMATION WERE NOT SUCCESSFUL. A DIAGNOSIS OF G6PD DEFICIENCY IS MADE IN CONJUNCTION WITH OTHER CLINICAL TESTS AND INFORMATION AND NOT SOL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10228701 ↗
• InjuryDec 17, 2019False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  A CUSTOMER IN PAKISTAN SUBMITTED A COMPLAINT OF DISCREPANT RESULTS WITH BINAXNOW G6PD. THE CUSTOMER REPORTED GENERATING A DEFICIENT RESULT WITH THE BINAXNOW G6PD ASSAY (SAMPLE TYPE NOT SPECIFIED). THE CUSTOMER STATED THAT ADDITIONAL PATIENT INFORMATION (CBC/PERIPHERAL BLOOD SMEAR, PATIENT HISTORY) WERE NOT SUGGESTIVE OF G6PD DEFICIENCY. THE BINAXNOW G6PD TEST WAS REPEATED, GENERATING NORMAL RESULTS. IT IS UNKNOWN IF THE REPEAT TESTING WAS PERFORMED ON THE SAME SAMPLE AND BINAXNOW G6PD KIT LOT. CONFIRMATION TESTING AND RESULTS ARE UNKNOWN. NO INJURY TO THE PATIENT WAS REPORTED. ATTEMPTS TO GAIN ADDITIONAL PATIENT INFORMATION WERE NOT SUCCESSFUL. LIMITATIONS PER THE PRODUCT INSERT: "LIMITATIONS THE BINAXNOW® G6PD TEST IS DESIGNED TO DISTINGUISH NORMAL LEVELS OF G6PD ENZYME ACTIVITY FROM DEFICIENT ENZYME ACTIVITY AND CANNOT BE USED TO ASSESS THE DEGREE OF DEFICIENCY. SAMPLES WHICH GENERATE A DEFICIENT RESULT ON THIS TEST SHOULD BE ASSAYED ON A QUANTITATIVE G6PD TEST. ABNORMALLY LOW AND HIGH HEMATOCRIT LEVELS CAN AFFECT TEST PERFORMANCE. G6PD IS NORMALLY FOUND IN THE RED BLOOD CELLS, AND A LOW HEMATOCRIT IS AN INDICATOR THAT THE NUMBER OF RED CELLS IS LOW IN A SPECIFIC VOLUME OF BLOOD.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9482180 ↗