Sure-Vue 4581405021Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00613647000533), received between May 8, 2018 and Jan 13, 2026 — classified as 3 injuries, 80 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (77 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-3271-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT WHILE USING SURE-VUE¿ SERUM/URINE HCG-STAT DEVICE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058434 ↗
• MalfunctionJan 8, 2026False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE TESTING 2 LOTS OF SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES ON A SINGLE PATIENT. THE PATIENT PRESENTED FOR AN UNSPECIFIED PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT PROVIDED A URINE SAMPLE FOR HCG TESTING WHICH WAS CLEAR YELLOW IN COLOR. THE URINE SAMPLE WAS TESTED USING A SURE-VUE¿ SERUM/URINE HCG-STAT DEVICE (LOT NUMBER 0000972178). THE RESULT WAS READ AT 3 MINUTES AND A FAINT FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT INDICATED THEY WERE NOT SEXUALLY ACTIVE; THEREFORE, TWO ADDITIONAL SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES WERE TESTED (ONE FROM LOT NUMBER 0000982191 AND THE SECOND FROM LOT NUMBER 0000972178). BOTH TESTS WERE READ AT 3 MINUTES, AND ADDITIONAL FAINT FALSE POSITIVE HCG RESULTS WERE OBTAINED. CONFIRMATORY SERUM TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. THE CUSTOMER REPORTED TESTING WITH BOTH LOTS USING POSITIVE AND NEGATIVE CONTROLS YIELDED PASSING RESULTS. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. EMDR 2027969-2026-00001 FOR THE FALSE POSITIVES ON LOT NUMBER 0000972178.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012777 ↗
• MalfunctionJan 8, 2026False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE TESTING 2 LOTS OF SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES ON A SINGLE PATIENT. THE PATIENT PRESENTED FOR AN UNSPECIFIED PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT PROVIDED A URINE SAMPLE FOR HCG TESTING WHICH WAS CLEAR YELLOW IN COLOR. THE URINE SAMPLE WAS TESTED USING A SURE-VUE¿ SERUM/URINE HCG-STAT DEVICE (LOT NUMBER 0000972178). THE RESULT WAS READ AT 3 MINUTES AND A FAINT FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT INDICATED THEY WERE NOT SEXUALLY ACTIVE; THEREFORE, TWO ADDITIONAL SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES WERE TESTED (ONE FROM LOT NUMBER 0000982191 AND THE SECOND FROM LOT NUMBER 0000972178). BOTH TESTS WERE READ AT 3 MINUTES, AND ADDITIONAL FAINT FALSE POSITIVE HCG RESULTS WERE OBTAINED. CONFIRMATORY SERUM TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. THE CUSTOMER REPORTED TESTING WITH BOTH LOTS USING POSITIVE AND NEGATIVE CONTROLS YIELDED PASSING RESULTS. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. EMDR (B)(4) FOR THE FALSE POSITIVE ON LOT NUMBER 0000982191.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012561 ↗
• MalfunctionDec 18, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING 2 FALSE POSITIVE HCG RESULTS WHILE USING SURE-VUE¿ SERUM/URINE HCG-STAT TESTS ON A PATIENT. THE PATIENT PRESENTED FOR HCG TESTING PRIOR TO UNDERGOING A CT SCAN WITH CONTRAST. THE PATIENT PROVIDED A URINE SAMPLE CLEAR YELLOW WITH NO VISIBLE PRECIPITATES. THE URINE WAS TESTED AND A POSITIVE HCG RESULT WAS OBTAINED. TWO REPEAT TESTS WERE PERFORMED USING DEVICES FROM THE SAME LOT, AND A NEGATIVE RESULT WAS OBTAINED ON THE FIRST DEVICE AND POSITIVE RESULT WAS OBTAINED ON THE SECOND. CONFIRMATORY BLOOD TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. AS A RESULT OF THE FALSE POSITIVE HCG RESULTS, THE PATIENT'S CT SCAN WAS DELAYED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840817 ↗
• MalfunctionDec 4, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING 2 FALSE POSITIVE HCG RESULTS WHILE USING THE FISHER SURE-VUE HCG STAT TESTS ON A PATIENT. THE PATIENT PRESENTED FOR HCG TESTING PRIOR TO UNDERGOING AN IUD PLACEMENT PROCEDURE. A FRESH URINE SAMPLE WAS TESTED WHICH RESULTED IN A POSITIVE HCG RESULT. A SECOND TEST WAS PERFORMED USING A DEVICE FROM THE SAME LOT WHICH YIELDED AN ADDITIONAL POSITIVE HCG RESULT. CONFIRMATORY SERUM TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. THE CUSTOMER REPORTED THE PATIENT EXPERIENCED MENTAL ANGUISH AS A RESULT OF THE POSITIVE RESULTS. NO TREATMENT WAS REQUIRED TREAT THE MENTAL ANGUISH, HOWEVER, AS A RESULT OF THE POSITIVE RESULT, THE IUD PLACEMENT PROCEDURE WAS DELAYED. NO NEGATIVE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720486 ↗
• MalfunctionDec 3, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED FALSE POSITIVE HCG RESULTS ON MEN WHILE USING SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23710657 ↗
• MalfunctionDec 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE DISTRIBUTOR REPORTED FALSE RESULTS WHILE USING THE SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698819 ↗
• MalfunctionNov 27, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE RESULTS WHILE USING THE FISHER SURE-VUE HCG STAT SERUM/URINE DEVICE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669082 ↗
• MalfunctionNov 27, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE RESULTS WHILE USING THE FISHER SURE-VUE HCG STAT SERUM/URINE DEVICE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669079 ↗
• MalfunctionNov 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING SURE-VUE SERUM/URINE HCG-STAT DEVICES WITH 3 DIFFERENT LOTS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED REGARDING EVENTS WITH LOT NUMBER 0000972178. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. PLEASE NOTE: THE CUSTOMER PROVIDED SPECIFIC PATIENT INFORMATION AND DETAILS REGARDING 1 PATIENT THAT USED LOT NUMBER 0000972178. THE REPORT FOR THAT INCIDENT HAS ALREADY BEEN REPORTED UNDER 2027969-2025-00206-00. ALTHOUGH REQUESTED FROM THE CUSTOMER, IT IS UNCLEAR IF THERE HAVE BEEN ANY OTHER FALSE POSITIVE INSTANCES WITH LOT 0000972178. WE ARE CONSERVATIVELY REPORTING THIS INCIDENT ON THIS LOT. SEE 2027969-2025-00231 AND 2027969-2025-00229 FOR LOTS 0000958539 AND 0000982191 RESPECTIVELY. PLEASE NOTE: THIS EMDR IS A DUPLICATE OF 2027969-2025-00230-00 WHICH THUS FAR HAS BEEN UNSUCCESSFULLY SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623989 ↗
• MalfunctionNov 20, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED RECEIVING 11 RETURNED UNITS OF SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES DUE TO "SHOWING FALSE POSITIVES". ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612797 ↗
• MalfunctionNov 17, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS WHEN TESTING WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DETAILS. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576832 ↗
• MalfunctionNov 17, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES WITH 3 DIFFERENT LOTS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED REGARDING EVENTS WITH LOT NUMBER 0000982191. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE 2027969-2025-00230 AND 2027969-2025-00231 FOR LOTS 0000958539 AND 0000972178 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576727 ↗
• MalfunctionNov 17, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS WHEN TESTING WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DETAILS. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576430 ↗
• MalfunctionNov 17, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES WITH 3 DIFFERENT LOTS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED REGARDING EVENTS WITH LOT NUMBER 0000958539. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE 2027969-2025-00230 AND 2027969-2025-00229 FOR LOTS 0000972178 AND 0000982191 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576344 ↗
• MalfunctionNov 17, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING SURE-VUE¿ SERUM/URINE HCG-STAT DEVICES WITH 3 DIFFERENT LOTS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED REGARDING EVENTS WITH LOT NUMBER 0000972178. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. PLEASE NOTE: THE CUSTOMER PROVIDED SPECIFIC PATIENT INFORMATION AND DETAILS REGARDING 1 PATIENT THAT USED LOT NUMBER 0000972178. THE REPORT FOR THAT INCIDENT HAS ALREADY BEEN REPORTED UNDER 2027969-2025-00206-00. ALTHOUGH REQUESTED FROM THE CUSTOMER, IT IS UNCLEAR IF THERE HAVE BEEN ANY OTHER FALSE POSITIVE INSTANCES WITH LOT 0000972178. WE ARE CONSERVATIVELY REPORTING THIS INCIDENT ON THIS LOT. SEE 2027969-2025-00230 AND 2027969-2025-00232 FOR LOTS 0000958539 AND 0000982191 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576295 ↗
• MalfunctionNov 12, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE CUSTOMER NOTED THAT A DARK CONTROL LINE APPEARED, AS WELL AS A "RED SMEAR" IN THE TEST LINE REGION. TWO MORE TESTS WERE RUN, EACH WITH A NEGATIVE RESULT, AND THE PATIENT WAS DETERMINED NOT TO BE PREGNANT. NO PATIENT INFORMATION COULD BE PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535871 ↗
• MalfunctionNov 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT WHILE USING THE SURE-VUE¿ SERUM/URINE HCG-STAT DEVICE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501625 ↗
• MalfunctionOct 31, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WHEN TESTING A PATIENT WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT PROVIDED A URINE SAMPLE WHICH WAS TESTED WITH THE SURE-VUE SERUM/URINE HCG-STAT AND YIELDED A POSITIVE RESULT. A LAB TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE. THE PATIENT RETURNED FOR A SUBSEQUENT VISIT, AND AGAIN A URINE SAMPLE WAS TESTED USING THE SURE-VUE SERUM/URINE HCG-STAT. THE RESULT WAS POSITIVE, HOWEVER REPEAT TESTING WITH A DEVICE FROM THE SAME LOT YIELDED A NEGATIVE RESULT. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439365 ↗
• MalfunctionOct 15, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG STAT COMBO DEVICES ON 2 PATIENTS. THE SECOND PATIENT PRESENTED ON (B)(6)2025 FOR HCG TESTING PRIOR TO UNDERGOING AN UNSPECIFIED PROCEDURE. A URINE SAMPLE WAS PROVIDED BY THE PATIENT WHICH APPEARED CLEAR AND FREE OF CONTAMINANTS. THE SAMPLE WAS TESTED, THE RESULTS WERE READ AT 3 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED. THE PATIENT'S URINE WAS TESTED AN ADDITIONAL TIME WHICH ALSO YIELDED A POSITIVE RESULT. CONFIRMATORY HCG SERUM TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. AS A RESULT OF THE POSITIVE HCG RESULTS, THE PROCEDURE WAS DELAYED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.SEE MDR 2027969-2025-00209 REGARDING PATIENT 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306290 ↗
• MalfunctionOct 15, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG STAT COMBO DEVICES ON 2 PATIENTS. THE FIRST PATIENT PRESENTED ON (B)(6) 2025 FOR HCG TESTING PRIOR TO UNDERGOING AN UNSPECIFIED PROCEDURE. A URINE SAMPLE WAS PROVIDED BY THE PATIENT WHICH APPEARED CLEAR AND FREE OF CONTAMINANTS. THE SAMPLE WAS TESTED, THE RESULTS WERE READ AT 3 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED. THE PATIENT'S URINE WAS TESTED 2 ADDITIONAL TIMES WHICH YIELDED NEGATIVE RESULTS. AS A RESULT OF THE DISCREPANT RESULTS, THE PROCEDURE WAS DELAYED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDR 2027969-2025-00210 REGARDING PATIENT 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304785 ↗
• MalfunctionOct 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WHEN TESTING A PATIENT URINE SAMPLE WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT HAD GIVEN BIRTH APPROXIMATELY 15 MONTHS PRIOR. A SERUM SAMPLE WAS TESTED IN THE LAB WITH A NEGATIVE RESULT (VALUE NOT PROVIDED). AN ULTRASOUND WAS PERFORMED TO RULE OUT THE POSSIBILITY OF AN ECTOPIC PREGNANCY. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23236714 ↗
• MalfunctionSep 12, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT WAS BEING SCREENED FROM PREGNANCY PRIOR TO A LAPAROSCOPIC SALPINGECTOMY. A BLOOD SAMPLE WAS COLLECTED AND TESTED USING THE BECKMAN COULTER ACCESS 2 BETA-HCG IMMUNOASSAY, WITH A RESULT OF <1 MIU/ML. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT'S HEALTH AS A RESULT OF THE FALSE POSITIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042490 ↗
• MalfunctionAug 4, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVES WHILE USING THE FISHER SURE-VUE HCG STAT COMBO DEVICE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710190 ↗
• MalfunctionJun 27, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG SERUM/URINE TESTS. IT IS UNCLEAR THE NUMBER OF FALSE RESULTS THAT WERE OBTAINED; HOWEVER THE CUSTOMER INDICATED CONFIRMATORY BLOOD TESTING CAME BACK AS NEGATIVE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351588 ↗