Sure-Vue 4581395021Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00613647000571), received between May 8, 2018 and Feb 16, 2026 — classified as 5 injuries, 40 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (33 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS ON AN UNSPECIFIED NUMBER OF PATIENTS WHILE USING SURE-VUE¿ SERUM/URINE HCG-STAT TESTS. TECHNICAL SERVICES ATTEMPTED TO GATHER ADDITIONAL INFORMATION; HOWEVER THE CUSTOMER ONLY RESPONDED INDICATING "THE ISSUE STEMMED FROM THE CLINIC NOT ALLOWING THE URINE TO COME TO ROOM TEMPERATURE. THERE WERE NO ISSUES WITH THE KITS." ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. ACCORDING TO THE PACKAGE INSERT. "ALLOW THE TEST DEVICE, SERUM OR URINE SPECIMEN AND/OR CONTROLS TO EQUILIBRATE TO ROOM TEMPERATURE (15-30°C) PRIOR TO TESTING." THIS EVENT IS CONSERVATIVELY BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349825 ↗
• MalfunctionJan 22, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE USING THE SURE-VUE SERUM/URINE HCG-STAT, LOT 0000964417. THE PATIENT WAS BEING SCREENED FOR PREGNANCY PRIOR TO REMOVAL OF AN IUD. THE INITIAL TEST WAS PERFORMED WITHIN MINUTES OF COLLECTION OF THE URINE SAMPLE AND YIELDED A POSITIVE RESULT. THE URINE SAMPLE WAS TAKEN TO THE LAB, WHERE IT WAS RETESTED WITH A SURE-VUE SERUM/URINE HCG-STAT TEST FROM LOT 0001135519 AND YIELDED A NEGATIVE RESULT. THE SAMPLE WAS THEN SPUN DOWN AND RETESTED WITH LOT 0001135519, AGAIN YIELDING A NEGATIVE RESULT. THE IUD REMOVAL WAS DELAYED DUE TO THE INITIAL POSITIVE RESULT, HOWEVER THE CUSTOMER CONFIRMED THAT THIS DELAY DID NOT LEAD TO ANY ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24155001 ↗
• MalfunctionDec 30, 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 WAS BEING SCREENED PRIOR TO UNDERGOING A MASTECTOMY. THE SAMPLE WAS TESTED USING THREE SURE-VUE SERUM/URINE HCG-STAT CASSETTES FROM LOT 0001135519; TWO CASSETTES YIELDED POSITIVE RESULTS WHILE THE THIRD YIELDED A NEGATIVE RESULT. A SERUM SAMPLE WAS COLLECTED AND TESTED USING LOT 0000972178, WHICH YIELDED A NEGATIVE RESULT. QUANTITATIVE BETA-HCG TESTING WAS PERFORMED ON THE SERUM SAMPLE WITH A RESULT OF 0.17 MIU/ML. THE PATIENT EXPRESSED ANXIETY AT THE POTENTIAL PREGNANCY. THE SURGERY AND PROVISION OF PRE-SURGICAL ANTI-ANXIETY MEDICATION WERE DELAYED BY APPROXIMATELY ONE HOUR. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: Anxiety

  MAUDE report 23923717 ↗
• MalfunctionNov 6, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN TESTING A PATIENT WITH THE SURE-VUE SERUM/URINE HCG-STAT. A BLOOD DRAW WAS PERFORMED AND AN ALTERNATE CONFIRMATORY METHOD WAS USED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23492958 ↗
• MalfunctionNov 6, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT WITH THE SURE-VUE SERUM/URINE HCG-STAT. A BLOOD DRAW WAS PERFORMED AND AN ALTERNATE CONFIRMATORY METHOD WAS USED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23492941 ↗
• MalfunctionNov 6, 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 WAS BEING TESTED PRIOR TO REMOVAL OF AN IUD. SERUM HCG TESTING (METHOD NOT SPECIFIED) WAS PERFORMED THE SAME DAY AND YIELDED A NEGATIVE RESULT. NO NEGATIVE IMPACT TO THE PATIENT'S HEALTH WAS REPORTED AS A RESULT OF THE DELAY IN IUD REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491811 ↗
• MalfunctionAug 11, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING 3 TO 4 FALSE POSITIVE HCG RESULTS WHILE USING FISHER SURE-VUE HCG STAT SERUM/URINE TESTS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778388 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS FOR 2 PATIENTS WHILE USING FISHER SURE-VUE HCG STAT COMBO DEVICES. THE SECOND PATIENT PRESENTING FOR HCG TESTING, PRIOR TO UNDERGOING AN IUD REMOVAL AND RE-IMPLANTATION PROCEDURE. A URINE SAMPLE WAS COLLECTED WHICH WAS CLEAR IN APPEARANCE. THE SAMPLE WAS TESTED, THE RESULT WAS READ AT 4 MINUTES, AND A FAINT POSITIVE RESULT WAS OBSERVED. THE SAME URINE SAMPLE WAS THEN RETESTED USING ANOTHER DEVICE FROM THE SAME LOT AND A NEGATIVE HCG RESULT WAS OBSERVED. AS A RESULT OF THE CONFLICTING HCG RESULTS, THE IUD PROCEDURE WAS CANCELLED. CONFIRMATORY BHCG SERUM TESTING WAS THEN PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. THE IUD PROCEDURE WAS RESCHEDULED FOR LATER THAT SAME DAY. THE CUSTOMER REPORTED THE PATIENT EXPERIENCED CONFUSION/PANIC AS A RESULT OF THE FALSE POSITIVE HCG RESULT, HOWEVER THERE IS NO INDICATION THAT THE PATIENT REQUIRED MEDICAL INTERVENTION. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDR 2027969-2025-00164 FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647111 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS FOR 2 PATIENTS WHILE USING FISHER SURE-VUE HCG STAT COMBO DEVICES. THE FIRST PATIENT PRESENTING FOR HCG TESTING, PRIOR TO UNDERGOING AN UNSPECIFIED PROCEDURE. A URINE SAMPLE WAS COLLECTED WHICH WAS CLEAR IN APPEARANCE. THE SAMPLE WAS TESTED, THE RESULT WAS READ AT 4 MINUTES, AND A POSITIVE RESULT WAS OBSERVED. THE SAME URINE SAMPLE WAS THEN RETESTED TWO ADDITIONAL TIMES USING DEVICES FROM THE SAME LOT AND NEGATIVE HCG RESULTS WERE OBSERVED. THE CUSTOMER REPORTED THE PATIENT WAS UNAWARE OF THE FALSE POSITIVE RESULT, HOWEVER THEY REPORTEDLY STILL EXPERIENCED CONFUSION/PANIC. THERE IS NO INDICATION THAT THE PATIENT REQUIRED MEDICAL INTERVENTION FOR TREATMENT OF THESE SYMPTOMS. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MDR 2027969-2025-00165 FOR THE SECOND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647084 ↗
• MalfunctionJun 25, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT SERUM SAMPLE WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT PRESENTED WITH DEPRESSION. THE RESULT WAS READ LESS THAN 3 MINUTES AFTER INITIATION OF THE TEST. ANOTHER SERUM SAMPLE WAS COLLECTED AND TESTED ON THE SIEMENS DIMENSION EXL, WITH A NEGATIVE RESULT OF <1. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT FROM THE FALSE POSITIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332761 ↗
• MalfunctionMay 23, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WHEN TESTING A PATIENT WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT WAS BEING SCREENED PRIOR TO RECEIVING AN IUD. THE PATIENT WAS TESTED A TOTAL OF THREE TIMES, EACH TIME WITH A POSITIVE RESULT. THE PATIENT WAS SENT FOR A LAB TEST AND WAS DETERMINED NOT TO BE PREGNANT. THE PATIENT DID NOT RETURN FOR THE IUD PLACEMENT. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH TWO ADDITIONAL PATIENTS. SEE H10 FOR THE RELATED MDR NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081111 ↗
• MalfunctionMay 23, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FOUR FALSE POSITIVE RESULTS WHEN TESTING A PATIENT WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT WAS POST-PARTUM (DELIVERY DATE NOT PROVIDED) AND WAS BEING SCREENED PRIOR TO RECEIVING AN IUD. THE PATIENT HAD TO RETURN TO THE CLINIC ON THREE OCCASIONS DUE TO THE FALSE POSITIVE RESULTS. THE IUD INSERTION WAS DELAYED 5 WEEKS AND 2 DAYS. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH TWO ADDITIONAL PATIENTS. SEE H10 FOR THE RELATED MDR NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081098 ↗
• MalfunctionMay 23, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE USING THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT PRESENTED WITH DYSURIA AND WAS BEING SEEN AFTER A POSSIBLE EXPOSURE TO AN STI. THE CUSTOMER WAS UNABLE TO VERIFY WHETHER THE PATIENT WAS TESTED WITH LOT NUMBER 0000875761 OR 0000857529. ADDITIONAL TESTING FOR STIS AND A URINE CULTURE WERE PERFORMED FOLLOWING THE POSITIVE HCG RESULT. NO ADVERSE EVENTS WERE REPORTED. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH TWO ADDITIONAL PATIENTS. SEE H10 FOR THE RELATED MDR NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081095 ↗
• MalfunctionMay 7, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED 3 TO 4 FALSE POSITIVE RESULTS WHEN USING THE SURE-VUE SERUM/URINE HCG-STAT. NO ADDITIONAL DETAILS WERE PROVIDED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981004 ↗
• MalfunctionMay 2, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A FALSE POSITIVE HCG RESULT WHILE USING THE FISHER SURE-VUE HCG STAT SERUM/URINE DEVICE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955109 ↗
• MalfunctionMar 26, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING SEVERAL FALSE POSITIVE HCG RESULTS WHILE TESTING FISHER SURE-VUE HCG STAT SERUM/URINE TESTS. THE CUSTOMER WAS ONLY ABLE TO PROVIDE SPECIFIC DETAILS REGARDING 1 PATIENT (SEE MDR 2027969-2025-00075). HOWEVER, THE CUSTOMER INDICATED OBSERVING A TREND IN 2-3 KITS WHERE SEVERAL TESTS WERE SHOWING FALSE POSITIVE HCG RESULTS AND THEN CONFIRMATORY HCG TESTING WAS NEGATIVE. ALTHOUGH REQUESTED, THE CUSTOMER DOES NOT HAVE ANY OTHER INFORMATION TO SHARE IN REGARD TO THESE ADDITIONAL FALSE HCG TEST RESULTS. SEE MDR 2027969-2025-00075 REGARDING FALSE POSITIVE EVENT ON PATIENT 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701978 ↗
• MalfunctionMar 26, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING SEVERAL FALSE POSITIVE HCG RESULTS WHILE TESTING FISHER SURE-VUE HCG STAT SERUM/URINE TESTS. THE CUSTOMER REPORTED ONE PATIENT PRESENTED FOR TESTING DUE TO NOT HAVING A RECENT MENSES. THE PATIENT PROVIDED A FRESH URINE SAMPLE, AND NO ISSUES WERE NOTED REGARDING SPECIMEN COLLECTION OR APPEARANCE. THE SAMPLE WAS TESTED, AND THE RESULTS WERE READ AT 3 MINUTES. THE FIRST DEVICE YIELDED A NEGATIVE HCG AND TESTING WITH A SECOND DEVICE YIELDED A POSITIVE HCG RESULT. CONFIRMATORY HCG BLOOD TESTING YIELDED A NEGATIVE HCG RESULT. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2025-00076 REGARDING ADDITIONAL UNSPECIFIED NUMBER FALSE POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701452 ↗
• MalfunctionNov 4, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT WHILE USING A FISHER SURE-VUE HCG STAT SERUM/URINE TEST. THE PATIENT PRESENTED TO THE EMERGENCY ROOM DISORIENTED. A FRESH SERUM SAMPLE WAS COLLECTED AND TESTED USING THE FISHER SURE-VUE DEVICE. A NEGATIVE RESULT WAS OBTAINED AT 5 MINUTES AND A FAINT POSITIVE RESULT WAS OBTAINED AT 6 MINUTES. CONFIRMATORY TESTING WAS PERFORMED ON 12OCT2024 AND 14OCT2024 AND BOTH RESULTS YIELDED NEGATIVE RESULTS. NO ADVERSE EVENTS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604102 ↗
• MalfunctionSep 25, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED TWO FALSE NEGATIVE RESULTS WHEN TESTING A PATIENT SERUM SAMPLE USING THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT WAS BEING SCREENED FOR PREGNANCY. A URINE SAMPLE WAS COLLECTED AND TESTED TWICE, EACH TIME YIELDING A FAINT POSITIVE RESULT. A SERUM SAMPLE WAS COLLECTED AND TESTED TWICE, EACH TIME WITH A NEGATIVE RESULT. QUANTITATIVE BETA-HCG TESTING WAS THEN PERFORMED ON THE SERUM SAMPLE TWICE, WITH RESULTS OF 30 MIU/ML AND 27 MIU/ML. AN ULTRASOUND WAS PERFORMED, AND NO EVIDENCE OF PREGNANCY WAS FOUND. THE PATIENT WAS ULTIMATELY DIAGNOSED WITH A MALIGNANT NEOPLASM OF THE STOMACH. THE PATIENT EXPERIENCED SOME ANXIETY OVER THE RESULTS, HOWEVER NO INTERVENTION WAS REQUIRED TO TREAT THE ANXIETY. NO ADVERSE OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302737 ↗
• MalfunctionJun 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 4 FALSE POSITIVE RESULTS FOR 1 PATIENT WHILE USING FISHER SURE-VUE HCG CASSETTES. THE PATIENT INITIALLY PRESENTED FOR A HIP PROCEDURE ON (B)(6) 2024, PRIOR TO THE PROCEDURE, THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED ON THE FISHER SURE-VUE HCG CASSETTE LOT 0000702333. THE RESULT WAS READ AT 3 MINUTES WHICH WAS POSITIVE. THE PATIENT WAS THEN TESTED AGAIN USING ANOTHER DEVICE FROM THE SAME LOT USING A SERUM SAMPLE. THE RESULTS WERE READ AT 5 MINUTES AND AN ADDITIONAL POSITIVE HCG RESULT WAS OBTAINED. FOLLOWING THE SECOND POSITIVE HCG RESULT, AN UNKNOWN SAMPLE TYPE WAS COLLECTED AT 0935 FOR QUANTITATIVE TESTING AND THE TEST YIELDED A VALUE OF 5.8 (UNITS NOT SPECIFIED). AS A RESULT OF THE POSITIVE HCG RESULTS, THE PATIENT'S HIP PROCEDURE WAS RESCHEDULED. THE PATIENT LATER PRESENTED ON (B)(6) 2024 FOR ADDITIONAL TESTING, THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED ON THE FISHER SURE-VUE HCG CASSETTE LOT 0000788119. THE RESULT WAS READ AT 3 MINUTES WHICH WAS POSITIVE. THE PATIENT WAS THEN TESTED AGAIN USING ANOTHER DEVICE FROM THE SAME LOT (0000788119) USING A SERUM SAMPLE. THE RESULTS WERE READ AT 5 MINUTES AND AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538483 ↗
• MalfunctionJun 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 4 FALSE POSITIVE RESULTS FOR 1 PATIENT WHILE USING FISHER SURE-VUE HCG CASSETTES. THE PATIENT INITIALLY PRESENTED FOR A HIP PROCEDURE ON (B)(6) 2024, PRIOR TO THE PROCEDURE, THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED ON THE FISHER SURE-VUE HCG CASSETTE LOT 0000702333. THE RESULT WAS READ AT 3 MINUTES WHICH WAS POSITIVE. THE PATIENT WAS THEN TESTED AGAIN USING ANOTHER DEVICE FROM THE SAME LOT USING A SERUM SAMPLE. THE RESULTS WERE READ AT 5 MINUTES AND AN ADDITIONAL POSITIVE HCG RESULT WAS OBTAINED. FOLLOWING THE SECOND POSITIVE HCG RESULT, AN UNKNOWN SAMPLE TYPE WAS COLLECTED AT 0935 FOR QUANTITATIVE TESTING AND THE TEST YIELDED A VALUE OF 5.8 (UNITS NOT SPECIFIED). AS A RESULT OF THE POSITIVE HCG RESULTS, THE PATIENT'S HIP PROCEDURE WAS RESCHEDULED. THE PATIENT LATER PRESENTED ON (B)(6) 2024 FOR ADDITIONAL TESTING, THE PATIENT PROVIDED A FRESH URINE SAMPLE WHICH WAS TESTED ON THE FISHER SURE-VUE HCG CASSETTE LOT 0000788119. THE RESULT WAS READ AT 3 MINUTES WHICH WAS POSITIVE. THE PATIENT WAS THEN TESTED AGAIN USING ANOTHER DEVICE FROM THE SAME LOT (0000788119) USING A SERUM SAMPLE. THE RESULTS WERE READ AT 5 MINUTES AND AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538463 ↗
• MalfunctionApr 24, 2024False Positive Result; False Positive Result

  THE CUSTOMER ALSO REPORTED FALSE POSITIVE RESULTS WHEN TESTING URINE AND SERUM SAMPLES FROM ONE PATIENT. THE PATIENT WAS BEING SCREENED PRIOR TO A COLONOSCOPY. THE INITIAL URINE TEST YIELDED A FAINT TEST LINE AND WAS INTERPRETED AS POSITIVE. THE URINE SAMPLE WAS RETESTED, HOWEVER THE RESULT WAS NOT SPECIFIED. A SERUM SAMPLE WAS THEN COLLECTED AND TESTED WITH THE SURE-VUE SERUM/URINE HCG-STAT, YIELDING A SIMILAR FAINT POSITIVE RESULT. FINALLY, A QUANTITATIVE BETA HCG TEST WAS PERFORMED WITH A RESULT OF 3 U/L, AND THE PATIENT WAS DETERMINED NOT TO BE PREGNANT. THE COLONOSCOPY WAS DELAYED BY APPROXIMATELY AN HOUR AND A HALF. NO ADVERSE OUTCOMES WERE REPORTED (H-10 FOR THE RELATED REPORT NUMBER DOCUMENTING THE EVENT ABOVE). THE FOLLOWING DAY, THE URINE SAMPLE WAS TESTED WITH AN ALTERNATE LOT AND YIELDED SIMILAR RESULTS. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177612 ↗
• MalfunctionApr 24, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN TESTING URINE AND SERUM SAMPLES FROM ONE PATIENT WITH THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT WAS BEING SCREENED PRIOR TO A COLONOSCOPY. THE INITIAL URINE TEST YIELDED A FAINT TEST LINE AND WAS INTERPRETED AS POSITIVE. THE URINE SAMPLE WAS RETESTED, HOWEVER THE RESULT WAS NOT SPECIFIED. A SERUM SAMPLE WAS THEN COLLECTED AND TESTED WITH THE SURE-VUE SERUM/URINE HCG-STAT, YIELDING A SIMILAR FAINT POSITIVE RESULT. FINALLY, A QUANTITATIVE BETA HCG TEST WAS PERFORMED WITH A RESULT OF 3 U/L, AND THE PATIENT WAS DETERMINED NOT TO BE PREGNANT. THE COLONOSCOPY WAS DELAYED BY APPROXIMATELY AN HOUR AND A HALF. NO ADVERSE OUTCOMES WERE REPORTED. ADDITIONAL TESTING WAS PERFORMED THE FOLLOWING DAY WITH AN ALTERNATE LOT AND YIELDED SIMILAR RESULTS. SEE H-10 FOR THE RELATED REPORT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177524 ↗
• InjuryFeb 22, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE USING THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT HAD BEEN EXPERIENCING ABDOMINAL PAIN FOR OVER A YEAR, AND FOLLOWING THE NEGATIVE HCG RESULT THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY WITH GENERAL ANESTHESIA. THE PATIENT TOOK AN AT-HOME PREGNANCY TEST 19 DAYS AFTER THE CHOLECYSTECTOMY WITH A POSITIVE RESULT, WHICH WAS CONFIRMED AT THE CLINIC FACILITY. THE PATIENT WAS DETERMINED TO HAVE BEEN THREE AND A HALF WEEKS PREGNANT AT THE TIME OF THE NEGATIVE RESULT, HOWEVER QUANTITATIVE TESTING WAS NOT PERFORMED AT THE TIME. WHILE IT IS UNKNOWN WHETHER THE HCG CONCENTRATION OF THE SAMPLE WAS ACTUALLY ABOVE THE LEVEL OF DETECTION OF THE SURE-VUE SERUM/URINE HCG-STAT, THIS IS CONSERVATIVELY BEING CONSIDERED A FALSE NEGATIVE. THE PREGNANCY WAS CONSIDERED VIABLE AS OF (B)(6) 2024; NO ADVERSE OUTCOMES WERE REPORTED. HOWEVER, DUE TO THE POTENTIAL FOR HARM TO THE FETUS DUE TO EXPOSURE TO ANESTHESIA, THIS WILL BE CONSIDERED AN OTHER SERIOUS/IMPORTANT MEDICAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758959 ↗
• InjuryFeb 14, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE USING THE SURE-VUE SERUM/URINE HCG-STAT. THE PATIENT HAD BEEN EXPERIENCING ABDOMINAL PAIN FOR OVER A YEAR, AND FOLLOWING THE NEGATIVE HCG RESULT THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY WITH GENERAL ANESTHESIA. THE PATIENT TOOK AN AT-HOME PREGNANCY TEST 19 DAYS AFTER THE CHOLECYSTECTOMY WITH A POSITIVE RESULT, WHICH WAS CONFIRMED AT THE CLINIC FACILITY. THE PATIENT WAS DETERMINED TO HAVE BEEN THREE AND A HALF WEEKS PREGNANT AT THE TIME OF THE NEGATIVE RESULT, HOWEVER QUANTITATIVE TESTING WAS NOT PERFORMED AT THE TIME. WHILE IT IS UNKNOWN WHETHER THE HCG CONCENTRATION OF THE SAMPLE WAS ACTUALLY ABOVE THE LEVEL OF DETECTION OF THE SURE-VUE SERUM/URINE HCG-STAT, THIS IS CONSERVATIVELY BEING CONSIDERED A FALSE NEGATIVE. THE PREGNANCY WAS CONSIDERED VIABLE AS OF 01-FEB-2024; NO ADVERSE OUTCOMES WERE REPORTED. HOWEVER, DUE TO THE POTENTIAL FOR HARM TO THE FETUS DUE TO EXPOSURE TO ANESTHESIA, THIS WILL BE CONSIDERED AN OTHER SERIOUS/IMPORTANT MEDICAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18708313 ↗