Sure-Vue 4581425021Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00613647000526), received between May 22, 2017 and Sep 3, 2025 — classified as 39 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (37 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-3274-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WHEN TESTING ONE PATIENT URINE SAMPLE WITH THE SURE-VUE URINE HCG. THE CUSTOMER STATED THAT THE PREGNANCY SCREENING WAS PERFORMED IN RELATION TO THE PATIENT'S MEDICATION USAGE, BUT DECLINED TO PROVIDE ANY FURTHER INFORMATION. A DIFFERENT BRAND OF PREGNANCY TEST WAS USED AND YIELDED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT THERE WAS NO NEGATIVE IMPACT TO THE PATIENT DUE TO THE FALSE POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959739 ↗
• MalfunctionAug 29, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED FALSE POSITIVE HCG RESULTS WHILE USING THE FISHER SURE-VUE HCG URINE CASSETTES. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923877 ↗
• MalfunctionJul 25, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS WHEN TESTING PATIENT SAMPLES WITH THE SURE-VUE URINE HCG. FOUR PATIENTS WERE TESTED, HOWEVER FOR ONE PATIENT RETESTS YIELDED POSITIVE RESULTS, AND THERE IS NO INDICATION THESE RESULTS WERE INACCURATE. RETESTING FOR TWO OF THE REMAINING THREE PATIENTS YIELDED NEGATIVE RESULTS; NO INFORMATION WAS PROVIDED FOR THE THIRD PATIENT. THREE ATTEMPTS WERE MADE TO OBTAIN FURTHER DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. THE CUSTOMER CONFIRMED THAT NO ADVERSE EVENTS OCCURRED. THIS MDR DOCUMENTS THE FALSE POSITIVE RESULTS FOR THE PATIENT FOR WHICH NO INFORMATION ON RETESTING WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22615925 ↗
• MalfunctionJul 25, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS WHEN TESTING PATIENT SAMPLES WITH THE SURE-VUE URINE HCG. FOUR PATIENTS WERE TESTED, HOWEVER FOR ONE PATIENT RETESTS YIELDED POSITIVE RESULTS, AND THERE IS NO INDICATION THESE RESULTS WERE INACCURATE. RETESTING FOR TWO OF THE REMAINING THREE PATIENTS YIELDED NEGATIVE RESULTS; NO INFORMATION WAS PROVIDED FOR THE THIRD PATIENT. THREE ATTEMPTS WERE MADE TO OBTAIN FURTHER DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. THE CUSTOMER CONFIRMED THAT NO ADVERSE EVENTS OCCURRED. THIS MDR DOCUMENTS THE FALSE POSITIVE RESULTS FOR THE SECOND PATIENT WITH NEGATIVE RESULTS UPON RETESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22615798 ↗
• MalfunctionJul 25, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS WHEN TESTING PATIENT SAMPLES WITH THE SURE-VUE URINE HCG. FOUR PATIENTS WERE TESTED, HOWEVER FOR ONE PATIENT RETESTS YIELDED POSITIVE RESULTS, AND THERE IS NO INDICATION THESE RESULTS WERE INACCURATE. RETESTING FOR TWO OF THE REMAINING THREE PATIENTS YIELDED NEGATIVE RESULTS; NO INFORMATION WAS PROVIDED FOR THE THIRD PATIENT. THREE ATTEMPTS WERE MADE TO OBTAIN FURTHER DETAILS, HOWEVER THE CUSTOMER WAS UNRESPONSIVE. THE CUSTOMER CONFIRMED THAT NO ADVERSE EVENTS OCCURRED. THIS MDR DOCUMENTS THE FALSE POSITIVE RESULTS FOR THE FIRST PATIENT WITH NEGATIVE RESULTS UPON RETESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22615775 ↗
• MalfunctionApr 1, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE CASSETTES FOR 2 PATIENTS. THE SECOND PATIENT PRESENTED FOR PREGNANCY TESTING PRIOR TO UNDERGOING AN ELECTIVE COLONOSCOPY PROCEDURE. THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED AND YIELDED A POSITIVE HCG RESULT. CONFIRMATORY TESTING WAS PERFORMED USING A FISHER SURE-VUE DEVICE FROM A DIFFERENT LOT WHICH YIELDED A NEGATIVE HCG RESULT. THE CUSTOMER CONSIDERED THE POSITIVE RESULT TO BE FALSE BASED ON THE PATIENT'S LAST MENSTRUAL PERIOD. NO ADVERSE EVENT OR NEGATIVE PATIENT IMPACT REPORTED. SEE MDR 2027969-2025-00078 FOR EVENT FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748755 ↗
• MalfunctionApr 1, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE CASSETTES FOR 2 PATIENTS. THE FIRST PATIENT PRESENTED FOR PREGNANCY TESTING PRIOR TO UNDERGOING AN UNSPECIFIED ELECTIVE PROCEDURE. THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED AND YIELDED A POSITIVE HCG RESULT. CONFIRMATORY SERUM TESTING WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. NO ADVERSE EVENT OR NEGATIVE PATIENT IMPACT REPORTED. SEE MDR 2027969-2025-00079 FOR EVENT FOR THE SECOND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21744485 ↗
• MalfunctionMar 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE RESULTS FROM 2 BOXES OF FISHER SURE-VUE HCG URINE CASSETTES. ALTHOUGH REQUESTED, NO FURTHER CLARIFYING DETAILS SURROUNDING THE EVENTS HAVE BEEN PROVIDED. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668853 ↗
• MalfunctionJan 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 9 FALSE POSITIVE HCG RESULTS WHILE USING 2 DIFFERENT LOTS OF FISHERS SURE-VUE HCG URINE CASSETTES OR 2 DIFFERENT PATIENTS. BOTH PATIENTS WERE TESTED PRIOR TO UNDERGOING SCHEDULED ORTHOPEDIC SURGERIES. THE SECOND PATIENT (B)(6) PROVIDED A FRESH URINE SAMPLE AT 10:45AM. THE URINE WAS TESTED USING A FISHER SURE-VUE CASSETTE FROM LOT 0000841655. THE RESULTS WERE READ AT 3-4 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED. THE PATIENT PROVIDED A SECOND URINE SAMPLE AT 10:50AM WAS THEN TESTED 4 ADDITIONAL TIMES USING FISHER SURE-VUE CASSETTES FROM LOT 0000833012 AND THE CUSTOMER REPORTED RECEIVING 3 FALSE POSITIVE HCG RESULTS. AS A RESULT OF THE POSITIVE HCG RESULTS, THE ORTHOPEDIC SURGICAL PROCEDURE WAS CANCELLED, AND THE CUSTOMER WAS SENT FOR CONFIRMATORY TESTING. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2025-00033 REGARDING THE 3 ADDITIONAL FALSE POSITIVE RESULTS ON PATIENT 2. SEE MDRS 2027969-2025-00031 AND 2027969-2025-00032 REGARDING FALSE POSITIVES ON PATIENT 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21268049 ↗
• MalfunctionJan 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 9 FALSE POSITIVE HCG RESULTS WHILE USING 2 DIFFERENT LOTS OF FISHERS SURE-VUE HCG URINE CASSETTES OR 2 DIFFERENT PATIENTS. BOTH PATIENTS WERE TESTED PRIOR TO UNDERGOING SCHEDULED ORTHOPEDIC SURGERIES. THE SECOND PATIENT (B)(6) PROVIDED A FRESH URINE SAMPLE AT 10:45AM. THE URINE WAS TESTED USING A FISHER SURE-VUE CASSETTE FROM LOT 0000841655. THE RESULTS WERE READ AT 3-4 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED. THE PATIENT PROVIDED A SECOND URINE SAMPLE AT 10:50AM WAS THEN TESTED 4 ADDITIONAL TIMES USING FISHER SURE-VUE CASSETTES FROM LOT 0000833012 AND THE CUSTOMER REPORTED RECEIVING 3 FALSE POSITIVE HCG RESULTS. AS A RESULT OF THE POSITIVE HCG RESULTS, THE ORTHOPEDIC SURGICAL PROCEDURE WAS CANCELLED, AND THE CUSTOMER WAS SENT FOR CONFIRMATORY TESTING. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2025-00034 REGARDING THE 1 FALSE POSITIVE RESULT ON PATIENT 2. SEE MDRS 2027969-2025-00031 AND 2027969-2025-00032 REGARDING FALSE POSITIVES ON PATIENT 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267936 ↗
• MalfunctionJan 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 9 FALSE POSITIVE HCG RESULTS WHILE USING 2 DIFFERENT LOTS OF FISHERS SURE-VUE HCG URINE CASSETTES OR 2 DIFFERENT PATIENTS. BOTH PATIENTS WERE TESTED PRIOR TO UNDERGOING SCHEDULED ORTHOPEDIC SURGERIES. THE FIRST PATIENT (B)(6) PROVIDED A FRESH URINE SAMPLE. THE URINE WAS TESTED USING A FISHER SURE-VUE CASSETTE FROM LOT 0000833012. THE RESULTS WERE READ AT 3-4 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED. THE SAME PATIENT SAMPLE WAS THEN TESTED 4 ADDITIONAL TIMES USING FISHER SURE-VUE CASSETTES FROM LOT 0000841655 AND THE CUSTOMER REPORTED RECEIVING 4 ADDITIONAL FALSE POSITIVE HCG RESULTS. AS A RESULT OF THE POSITIVE HCG RESULTS, THE ORTHOPEDIC SURGICAL PROCEDURE WAS CANCELLED, AND THE CUSTOMER WAS SENT FOR CONFIRMATORY TESTING. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2025-00031 REGARDING THE FIRST FALSE POSITIVE ON THE FIRST PATIENT. SEE MDRS 2027969-2025-00033 AND 2027969-2025-00034 REGARDING FALSE POSITIVES ON PATIENT 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267921 ↗
• MalfunctionJan 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 9 FALSE POSITIVE HCG RESULTS WHILE USING 2 DIFFERENT LOTS OF FISHER SURE-VUE HCG URINE CASSETTES OR 2 DIFFERENT PATIENTS. BOTH PATIENTS WERE TESTED PRIOR TO UNDERGOING SCHEDULED ORTHOPEDIC SURGERIES. THE FIRST PATIENT (B)(6) PROVIDED A FRESH URINE SAMPLE. THE URINE WAS TESTED USING A FISHER SURE-VUE CASSETTE FROM LOT 0000833012. THE RESULTS WERE READ AT 3-4 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED. THE SAME PATIENT SAMPLE WAS THEN TESTED 4 ADDITIONAL TIMES USING FISHER SURE-VUE CASSETTES FROM LOT 0000841655 AND THE CUSTOMER REPORTED RECEIVING 4 ADDITIONAL FALSE POSITIVE HCG RESULTS. AS A RESULT OF THE POSITIVE HCG RESULTS, THE ORTHOPEDIC SURGICAL PROCEDURE WAS CANCELLED, AND THE CUSTOMER WAS SENT FOR CONFIRMATORY TESTING. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2025-00032 REGARDING 4 ADDITIONAL FALSE POSITIVES ON THE FIRST PATIENT. SEE MDRS 2027969-2025-00033 AND 2027969-2025-00034 REGARDING FALSE POSITIVES ON PATIENT 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267897 ↗
• MalfunctionDec 27, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN TESTING THREE PATIENTS WITH THE SURE-VUE URINE HCG TEST. PATIENT (B)(6) IS A 23-YEAR-OLD FEMALE AND WAS TESTED ON (B)(6) 2024. THE PATIENT WAS RETESTED WITH SURE-VUE URINE HCG TEST LOT 0000867291 AND THE RESULT WAS NEGATIVE. A PLASMA SAMPLE WAS COLLECTED AND TESTED ON THE ROCHE COBAS 8000 WITH A RESULT OF <2.0 MIU/ML. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028332 ↗
• MalfunctionDec 27, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN TESTING THREE PATIENTS WITH THE SURE-VUE URINE HCG TEST. PATIENT (B)(6) IS A 32-YEAR-OLD FEMALE AND WAS TESTED ON (B)(6) 2024. THE PATIENT WAS RETESTED WITH SURE-VUE URINE HCG TEST LOT 0000867291 AND THE RESULT WAS NEGATIVE. A PLASMA SAMPLE WAS COLLECTED AND TESTED ON THE ROCHE COBAS 8000 WITH A RESULT OF <2.0 MIU/ML. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028330 ↗
• MalfunctionDec 27, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN TESTING THREE PATIENTS WITH THE SURE-VUE URINE HCG TEST. PATIENT PAT-007987 IS A 29-YEAR-OLD FEMALE AND WAS TESTED ON (B)(6) 2024. THE PATIENT WAS RETESTED WITH SURE-VUE URINE HCG TEST LOT 0000867291 AND THE RESULT WAS NEGATIVE. A PLASMA SAMPLE WAS COLLECTED AND TESTED ON THE ROCHE COBAS 8000 WITH A RESULT OF <2.0 MIU/ML. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028310 ↗
• MalfunctionDec 9, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WHEN TESTING A PATIENT SAMPLE WITH THE SURE-VUE URINE HCG TEST. THE PATIENT SAMPLE WAS TESTED A TOTAL OF THREE TIMES, WITH A FAINT TEST LINE APPEARING ON TWO OF THE DEVICES. A BLOOD TEST WAS PERFORMED USING THE SIEMENS CENTAUR SYSTEM WITH A RESULT OF <2 MIU/ML. THERE WAS NO ADVERSE IMPACT TO THE PATIENT AS A RESULT OF THE FALSE POSITIVE RESULTS. THE CUSTOMER ALSO REPORTED FALSE POSITIVE RESULTS FOR TWO OTHER PATIENTS. SEE H10 FOR THE RELATED MDR NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20886612 ↗
• MalfunctionDec 9, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT SAMPLE WITH THE SURE-VUE URINE HCG TEST. THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. THERE WAS NO ADVERSE IMPACT TO THE PATIENT AS A RESULT OF THE FALSE POSITIVE RESULTS. THE CUSTOMER ALSO REPORTED FALSE POSITIVE RESULTS FOR TWO OTHER PATIENTS. SEE H10 FOR THE RELATED MDR NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20886173 ↗
• MalfunctionDec 9, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT SAMPLE WITH THE SURE-VUE URINE HCG TEST. THE PATIENT WAS TESTED AS PART OF CONTRACEPTIVE COUNSELING. A BLOOD TEST WAS PERFORMED (METHOD NOT SPECIFIED) WITH A RESULT OF <2 MIU/ML. THE PATIENT WAS ULTIMATELY PROVIDED A DEPO-PROVERA INJECTION, THOUGH THE INJECTION WAS DELAYED DUE TO THE FALSE POSITIVE RESULT. NO ADVERSE OUTCOMES WERE REPORTED. THE CUSTOMER ALSO REPORTED FALSE POSITIVE RESULTS FOR TWO OTHER PATIENTS. SEE H10 FOR THE RELATED MDR NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20885725 ↗
• MalfunctionDec 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING 2 FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE CASSETTES FOR TWO PATIENTS. EACH PATIENT PRESENTED IN THE EMERGENCY ROOM FOR AN UNSPECIFIED REASON APPROXIMATELY SOME TIME IN (B)(6) 2024. THE CUSTOMER INDICATED CONFIRMATORY BLOOD TESTS WERE PERFORMED WHICH YIELDED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS REPORTED. SEE MDR 2027969-2024-00212 FOR THE EVENT REGARDING THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834467 ↗
• MalfunctionDec 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING 2 FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE CASSETTES FOR TWO PATIENTS. EACH PATIENT PRESENTED IN THE EMERGENCY ROOM FOR AN UNSPECIFIED REASON APPROXIMATELY SOME TIME IN (B)(6) 2024. THE CUSTOMER INDICATED CONFIRMATORY BLOOD TESTS WERE PERFORMED WHICH YIELDED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS REPORTED. SEE MDR 2027969-2024-00213 FOR THE EVENT REGARDING THE SECOND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834049 ↗
• MalfunctionNov 13, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING "A HIGH NUMBER OF FALSE POSITIVE TESTS" WHILE USING A LOT OF SURE-VUE URINE HCG CASSETTES. THE CUSTOMER REPORTED THE ISSUE STARTED ON 17OCT2024. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677140 ↗
• MalfunctionNov 8, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE CASSETTES FOR TWO PATIENTS. THE SECOND PATIENT PRESENTED TO EXPRESS CARE COMPLAINING OF EAR PAIN, COUGH, NAUSEA. A FRESH URINE SAMPLE WAS PROVIDED BY THE PATIENT WHICH WAS CLEAR IN APPEARANCE. THE URINE WAS TESTED USING A FISHER SURE-VUE HCG URINE CASSETTE, THE RESULTS WERE READ AT 3 MINUTES, AND A FALSE POSITIVE HCG RESULT WAS OBTAINED. THE PATIENT WAS SENT FOR CONFIRMATORY TESTING USING A SURE-VUE COMBO TEST AND DXI BETA HCG. THE RESULTS WERE REPORTED AS PENDING, HOWEVER THE CUSTOMER ADVISED THEY BELIEVED THE POSITIVE RESULT WAS FALSE AS THE PATIENT WAS NOT SEXUALLY ACTIVE. AS A RESULT OF THE FALSE POSITIVE HCG RESULT, THE PATIENT EXPERIENCED ANXIETY WHICH DID NOT REQUIRE MEDICAL TREATMENT. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2024-00191 FOR THE FALSE POSITIVE RESULTS ON THE FIRST PATIENT. NEW INFORMATION RECEIVED ON 27NOV2024, NOTED THE CUSTOMER SUBMITTED A TOTAL OF 4 MEDWATCH REPORTS FOR THESE 2 PATIENTS. THE CUSTOMER REPORTED THIS PATIENT PRESENTED COMPLAINING OF EAR PAIN, COUGH, AND NAUSEA. A FRESH URINE SAMPLE WAS TESTED 3 TIMES USING DEVICES FROM LOT 0000853388, AND FALSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641993 ↗
• MalfunctionNov 7, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE CASSETTES FOR TWO PATIENTS. THE FIRST PATIENT PRESENTED FOR AN EMERGENT ISSUE DUE TO ABDOMINAL PAIN THAT RADIATED TO THE LEFT SIDE OF THEIR BACK. THE PATIENT PROVIDED A FRESH URINE SAMPLE, THE RESULTS WERE READ AT 3 MINUTES, AND A POSITIVE HCG RESULT WAS OBTAINED. TESTING WITH A NEW UNSPECIFIED LOT OF CASSETTES YIELDED A NEGATIVE RESULT. ADDITIONALLY, AN ABDOMINAL ULTRASOUND WAS PERFORMED ON (B)(6) 2024 THAT YIELDED A NEGATIVE RESULT. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2024-00192 FOR THE FALSE POSITIVE RESULTS ON THE SECOND PATIENT. NEW INFORMATION RECEIVED ON (B)(6) 2024, NOTED THE CUSTOMER SUBMITTED A TOTAL OF 4 MEDWATCH REPORTS FOR THESE 2 PATIENTS. THREE OF THE MEDWATCH REPORTS ARE FOR MDR 2027969-2024-00192. THE FOURTH MEDWATCH FORM IS FOR THE PATIENT IN THIS MDR. THE MEDWATCH FORM FOR THIS EVENT INDICATED THE EVENT TOOK PLACE ON 17OCT2024. THE CUSTOMER CONFIRMED THIS INFORMATION TO BE ACCURATE AND THE MDR WILL BE UPDATED ACCORDINGLY. NO NEW INFORMATION WAS PROVIDED OTHER THAN THE EVENT DATE AND THE MEDWATCH NUMBER FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636330 ↗
• MalfunctionOct 26, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 5 FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE CASSETTES WITH FOUR PATIENTS. THE FIRST PATIENT PRESENTED WITH FLANK PAIN AND POSSIBLE KIDNEY STONES. THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED USING THE FISHER SURE-VUE HCG URINE CASSETTE AND A POSITIVE HCG RESULT WAS OBTAINED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR TREATMENT OF THE FLANK PAIN AND POSSIBLE KIDNEYS STONES. NO ADVERSE EVENT REPORTED. THE CUSTOMER ADDITIONALLY INDICATED A SERUM TEST WAS ALSO PERFORMED WHICH YIELDED A NEGATIVE RESULT; HOWEVER NO INFORMATION AS PROVIDED ON WHEN THE TEST WAS PERFORMED. SEE MDRS 2027969-2024-00185, 2027969-2024-00186, AND 2027969-2024-00187 FOR PATIENTS 2-4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20540150 ↗
• MalfunctionOct 25, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 5 FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG URINE CASSETTES WITH FOUR PATIENTS. THE FOURTH PATIENT PRESENTED FOR AN UNKNOWN REASON. A PREGNANCY TEST WAS PERFORMED AS THE PATIENT REPORTED NOT HAVING A PERIOD FOR 50 DAYS. THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED USING THE FISHER SURE-VUE HCG URINE CASSETTE AND A POSITIVE HCG RESULT WAS OBTAINED. TWO ADDITIONAL HCG TESTS WERE PERFORMED USING DEVICES FROM THE SAME LOT AND NEGATIVE RESULTS WERE OBTAINED. NO ADVERSE EVENTS WERE REPORTED. NO INFORMATION WAS PROVIDED. SEE MDRS 2027969-2024-00184, 2027969-2024-00185, AND 2027969-2024-00186 FOR PATIENTS 1-3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539112 ↗