Sure-Vue 4581415021Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613647000588), received between Nov 14, 2023 and Jul 2, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 20, 2026Class IIOpen, Classified

   hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

   Z-3273-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE DIPSTICKS ON AN UNKNOWN NUMBER OF PATIENTS WITH TWO LOTS. EACH PATIENT PRESENTED FOR A PREGNANCY CHECK PRIOR TO PERFORMING AN UNSPECIFIED NON-EMERGENT DIAGNOSTIC PROCEDURE. ALL OF THE PATIENTS PROVIDED A FRESH URINE SAMPLE THAT WAS TESTED IMMEDIATELY. THE RESULTS WERE READ AT 4 MINUTES AND POSITIVE HCG RESULTS WERE OBTAINED. AS A RESULT, THE DIAGNOSTIC PROCEDURES WERE DELAYED 24 HOURS AS CONFIRMATORY BLOOD TESTING WAS PERFORMED. NO ADVERSE EVENTS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. PER THE PACKAGE INSERT, "ALLOW THE TEST STRIP, URINE SPECIMEN AND/OR CONTROLS TO EQUILIBRATE TO ROOM TEMPERATURE (15-30°C) PRIOR TO TESTING." SEE MDR 2027969-2024-00088 FOR THE EVENT ON LOT NUMBER 0000695546.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662199 ↗
• MalfunctionJul 2, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE DIPSTICKS ON AN UNKNOWN NUMBER OF PATIENTS WITH TWO LOTS. EACH PATIENT PRESENTED FOR A PREGNANCY CHECK PRIOR TO PERFORMING AN UNSPECIFIED NON-EMERGENT DIAGNOSTIC PROCEDURE. ALL OF THE PATIENTS PROVIDED A FRESH URINE SAMPLE THAT WAS TESTED IMMEDIATELY. THE RESULTS WERE READ AT 4 MINUTES AND POSITIVE HCG RESULTS WERE OBTAINED. AS A RESULT, THE DIAGNOSTIC PROCEDURES WERE DELAYED 24 HOURS AS CONFIRMATORY BLOOD TESTING WAS PERFORMED. NO ADVERSE EVENTS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. PER THE PACKAGE INSERT, "ALLOW THE TEST STRIP, URINE SPECIMEN AND/OR CONTROLS TO EQUILIBRATE TO ROOM TEMPERATURE (15-30°C) PRIOR TO TESTING." SEE MDR 2027969-2024-00089 FOR THE EVENT ON LOT NUMBER 0000695335.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661311 ↗
• MalfunctionNov 14, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF FOUR FALSE POSITIVE HCG RESULTS ON THE SURE-VUE HCG URINE TEST FOR FOUR PATIENTS. THE FOUR PATIENTS WERE TESTED IN AN INFERTILITY CLINIC AND THE CUSTOMER REPORTED NOTED 3 FALSE POSITIVE RESULTS ON LOT HCG2042082 AND 1 ON LOT HCG2042074. A FRESH URINE SAMPLE WAS PROVIDED IN EACH INSTANCE AND THE SAMPLES APPEARED "NORMAL". THE CUSTOMER INDICATED THE TEST WAS PERFORMED ACCORDING TO THE PACKAGE INSERT AND THE RESULTS WERE READ AT 4 MINUTES. REPEAT TESTS WITH THE SAME KITS WERE PERFORMED FOR ALL FOUR PATIENTS AND NEGATIVE RESULTS WERE OBTAINED. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2023-00107 AND 2027969-2023-00109 FOR ADDITIONAL FALSE POSITIVE RESULTS ON LOT HCG2042082 AND MDR 2027969-2023-00108 FOR THE REPORTED FALSE POSITIVE ON LOT HCG2042074.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136219 ↗
• MalfunctionNov 14, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF FOUR FALSE POSITIVE HCG RESULTS ON THE SURE-VUE HCG URINE TEST FOR FOUR PATIENTS. THE FOUR PATIENTS WERE TESTED IN AN INFERTILITY CLINIC AND THE CUSTOMER REPORTED NOTED 3 FALSE POSITIVE RESULTS ON LOT HCG2042082 AND 1 ON LOT HCG2042074. A FRESH URINE SAMPLE WAS PROVIDED IN EACH INSTANCE AND THE SAMPLES APPEARED "NORMAL". THE CUSTOMER INDICATED THE TEST WAS PERFORMED ACCORDING TO THE PACKAGE INSERT AND THE RESULTS WERE READ AT 4 MINUTES. REPEAT TESTS WITH THE SAME KITS WERE PERFORMED FOR ALL FOUR PATIENTS AND NEGATIVE RESULTS WERE OBTAINED. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2023-00107 AND 2027969-2023-00110 FOR ADDITIONAL FALSE POSITIVE RESULTS ON LOT HCG2042082 AND MDR 2027969-2023-00108 FOR THE REPORTED FALSE POSITIVE ON LOT HCG2042074.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136193 ↗
• MalfunctionNov 14, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF FOUR FALSE POSITIVE HCG RESULTS ON THE SURE-VUE HCG URINE TEST FOR FOUR PATIENTS. THE FOUR PATIENTS WERE TESTED IN AN INFERTILITY CLINIC AND THE CUSTOMER REPORTED NOTED 3 FALSE POSITIVE RESULTS ON LOT HCG2042082 AND 1 ON LOT HCG2042074. A FRESH URINE SAMPLE WAS PROVIDED IN EACH INSTANCE AND THE SAMPLES APPEARED "NORMAL". THE CUSTOMER INDICATED THE TEST WAS PERFORMED ACCORDING TO THE PACKAGE INSERT AND THE RESULTS WERE READ AT 4 MINUTES. REPEAT TESTS WITH THE SAME KITS WERE PERFORMED FOR ALL FOUR PATIENTS AND NEGATIVE RESULTS WERE OBTAINED. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2023-00107, 2027969-2023-00110 AND 2027969-2023-00109 FOR ADDITIONAL FALSE POSITIVE RESULTS ON LOT HCG2042082.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18134400 ↗
• MalfunctionNov 14, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF FOUR FALSE POSITIVE HCG RESULTS ON THE SURE-VUE HCG URINE TEST FOR FOUR PATIENTS. THE FOUR PATIENTS WERE TESTED IN AN INFERTILITY CLINIC AND THE CUSTOMER REPORTED NOTED 3 FALSE POSITIVE RESULTS ON LOT HCG2042082 AND 1 ON LOT HCG2042074. A FRESH URINE SAMPLE WAS PROVIDED IN EACH INSTANCE AND THE SAMPLES APPEARED "NORMAL". THE CUSTOMER INDICATED THE TEST WAS PERFORMED ACCORDING TO THE PACKAGE INSERT AND THE RESULTS WERE READ AT 4 MINUTES. REPEAT TESTS WITH THE SAME KITS WERE PERFORMED FOR ALL FOUR PATIENTS AND NEGATIVE RESULTS WERE OBTAINED. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2023-00108 AND 2027969-2023-00109 FOR ADDITIONAL FALSE POSITIVE RESULTS ON LOT HCG2042082 AND MDR 2027969-2023-00110 FOR THE REPORTED FALSE POSITIVE ON LOT HCG2042074.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18134237 ↗