Sure-Vue 4581445021Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613647000540), received between Oct 18, 2017 and Jun 3, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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-3272-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECEIVING CONFLICTING HCG RESULTS WHILE USING FISHER SURE-VUE HCG SERUM/URINE DEVICES ON TWO DIFFERENT DATES. THE CUSTOMER REPORTED RUNNING A SURE-VUE TEST WHICH RESULTED IN A BROKEN TEST LINE (POSITIVE HCG RESULT). A RETEST WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED, AND IT IS UNCLEAR WHICH RESULT THE CUSTOMER SUSPECTED TO BE CORRECT. THE CUSTOMER ALSO INDICATED ADDITIONAL SIMILAR RESULTS WERE OBTAINED 2 DAYS LATER. SEE MDR 2027969-2025-00132 FOR BROKEN TEST LINE/NEGATIVE RESULTS WHICH OCCURRED TWO DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135011 ↗
• MalfunctionJun 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECEIVING CONFLICTING HCG RESULTS WHILE USING FISHER SURE-VUE HCG SERUM/URINE DEVICES ON TWO DIFFERENT DATES. THE CUSTOMER REPORTED RUNNING A SURE-VUE TEST WHICH RESULTED IN A BROKEN TEST LINE (POSITIVE HCG RESULT). THE TEST WAS REPEATED TWO ADDITIONAL TIMES AND SIMILAR RESULTS WERE OBTAINED. A NEW KIT WAS OPENED, AND THE DEVICE WAS TESTED USING THE SAME URINE AND A NEGATIVE HCG RESULT WAS OBTAINED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED, AND IT IS UNCLEAR WHICH RESULT THE CUSTOMER SUSPECTED TO BE CORRECT. ADDITIONALLY, THE CUSTOMER REPORTED THE SAME SITUATION HAPPENED 2 DAYS EARLIER, WHERE A BROKEN TEST LINE WAS OBSERVED. A RETEST WAS PERFORMED WHICH YIELDED A NEGATIVE HCG RESULT. NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED. SEE MDR 2027969-2025-00133 FOR BROKEN TEST LINE/NEGATIVE RESULT WHICH OCCURRED TWO DAYS PRIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134804 ↗
• MalfunctionMar 20, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WHEN TESTING A PATIENT URINE SAMPLE USING THE SURE-VUE SERUM/URINE HCG LOT 0000736982. THE PATIENT WAS BEING SCREENED FOR PREGNANCY PRIOR TO AN UNSPECIFIED DIAGNOSTIC SCOPE PROCEDURE, AND ASSERTED THAT SHE WAS NOT PREGNANT. A SERUM SAMPLE WAS COLLECTED AND TESTED WITH AN ALTERNATE LOT NUMBER (0000692980), AND THE RESULT WAS NEGATIVE. THE CUSTOMER ENSURED THAT THE CUSTOMER WAS THOROUGHLY HYDRATED AND A NEW URINE SAMPLE WAS COLLECTED AND TESTED WITH LOT 0000692980; THE RESULT WAS NEGATIVE. THE PATIENT WAS DETERMINED NOT TO BE PREGNANT, AND THE PROCEDURE WAS NOT WITHHELD. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942791 ↗
• MalfunctionDec 16, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT A PATIENT WITH ABDOMINAL PAIN ARRIVED AT THE HOSPITAL. AN HCG TEST WAS PERFORMED WITH A FALSE POSITIVE RESULT ON A URINE/SERUM CASSETTE USING A SERUM SAMPLE. A URINE SAMPLE WAS TESTED ON THE SAME URINE/SERUM CASSETTE WITH A NEGATIVE RESULT. CONFIRMATORY TESTING RESULT WITH PATIENT'S PLASMA WAS 8.0MIU/ML. NO TREATMENT WAS DELAYED OR MEDICATION PROVIDED BASED ON THE RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9474051 ↗
• MalfunctionSep 27, 2019False Positive Result; False Positive Result

  IT WAS REPORTED BY A CUSTOMER THAT ON (B)(6) 2018, A FEMALE PATIENT WAS TESTED AS A SCREENING PROCEDURE USED BY A STUDY CONDUCTED BY A UNIVERSITY. THE CUSTOMER STATED THE ENTITY ADMINISTERED AN HCG SERUM/URINE TEST AND A FALSE POSITIVE RESULT OCCURRED TWICE. IN ORDER TO BE ELIGIBLE FOR THE STUDY, THE PATIENTS CANNOT BE PREGNANT AS THEY WILL UNDERGO AN ELECTIVE MRI (MAGNETIC RESONANCE IMAGING) PROCEDURE. THE PATIENT SAMPLE WAS TESTED FOUR TIMES RESULTING IN TWO POSITIVE RESULTS FOLLOWED BY TWO NEGATIVE RESULTS. THE FIRST AND SECOND TEST SHOWED A LIGHT LINE ON THE TEST REGION WHICH WAS INTERPRETED AS POSITIVE. THE THIRD AND FOURTH TEST RESULTS WERE A CLEAR NEGATIVE. THE CUSTOMER CONFIRMED THAT NOT BEING ELIGIBLE FOR THE STUDY DID NOT AFFECT THE PATIENT HEALTH, NO ADVERSE OUTCOMES EXPERIENCED. THE CONFIRMATORY RESULTS ARE CONFIDENTIAL, A DIFFERENT GROUP OF THE STUDY PERFORMS CONFIRMATORY TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9127117 ↗
• MalfunctionSep 27, 2019False Positive Result; False Positive Result

  CUSTOMER CALLED TO REPORT UNCONFIRMED FALSE POSITIVE HCG URINE RESULT X1 ON SURE-VUE SERUM/URINE HCG. IT WAS REPORTED BY THE CUSTOMER THAT AN UNCONFIRMED FALSE POSITIVE HCG URINE RESULT OCCURRED ON (B)(6) 2018. A FEMALE PATIENT WAS TESTED AS A SCREENING PROCEDURE USED BY A STUDY CONDUCTED BY THE (B)(6). IN ORDER TO BE ELIGIBLE FOR THE STUDY, THE PATIENTS CANNOT BE PREGNANT AS THEY WILL UNDERGO AN ELECTIVE MRI PROCEDURE. THE PATIENT SAMPLE WAS TESTED TWO TIMES RESULTING IN ONE POSITIVE RESULT FOLLOWED BY A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT NOT BEING ELIGIBLE FOR THE STUDY DID NOT AFFECT THE PATIENT HEALTH, NO ADVERSE OUTCOMES EXPERIENCED. TROUBLESHOOTING OCCURRED WITH A DISCUSSION ABOUT THE FALSE POSITIVE TEST RESULTS AND POSSIBLE CAUSES INCLUDING TECHNIQUE STORAGE AND HANDLING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9127116 ↗
• MalfunctionSep 25, 2019False Positive Result; False Positive Result

  IT WAS REPORTED BY A LAB DIRECTOR THAT A PATIENT CAME INTO THE CLINIC FOR CONTRACEPTIVES AND A FALSE POSITIVE RESULT OCCURRED WITH THE HCG SERUM/URINE TEST. THE PATIENT TESTED POSITIVE ON HCG TEST BUT THE SERUM QUANT CAME BACK AT <2MIU/ML. THE PATIENT WAS INSTRUCTED TO COME BACK IN A FEW WEEKS. A SECOND RAPID TEST ALSO CAME BACK AS A FALSE POSITIVE. NO PATIENT OUTCOME PROVIDED; UNKNOWN IF PATIENT RECEIVED CONTRACEPTIVE TREATMENT. TROUBLE SHOOTING OCCURRED WITH A REVIEW OF STORAGE, TECHNIQUE, AND HANDLING - NO DEVIATIONS NOTED. TSS DISCUSSED USING ONLY CLEAR URINE SPECIMENS FREE OF PARTICULATES, VARIANCE OF HCG CLEARANCE RATES IN INDIVIDUALS POST PREGNANCY, AND POSSIBILITY OF HAMA INTERFERENCE.

  Patient problems: No Information

  MAUDE report 9114391 ↗
• MalfunctionSep 18, 2018False Negative Result; False Negative Result

  THE CUSTOMER REPORTED RECEIVING ONE FALSE NEGATIVE HCG RESULT USING A FISHER - SURE-VUE HCG SERUM/URINE TEST. SERUM HCG CONFIRMATORY TESTING INDICATED THE PATIENT WAS POSITIVE FOR PREGNANCY. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886612 ↗
• MalfunctionSep 18, 2018False Negative Result; False Negative Result

  THE CUSTOMER REPORTED RECEIVING TWO FALSE NEGATIVE HCG RESULTS USING A FISHER - SURE-VUE HCG SERUM/URINE TEST ON TWO PATIENTS. SERUM HCG CONFIRMATORY TESTING INDICATED BOTH PATIENTS WERE POSITIVE FOR PREGNANCY. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886447 ↗
• MalfunctionOct 18, 2017False Negative Result; False Negative Result

  ON (B)(6) 2017, A URINE SAMPLE WAS COLLECTED FROM THE PATIENT AT 10:00 PM AND TESTED USING A FISHER - SURE-VUE HCG SERUM/URINE CASSETTE AT 10:38 PM. THE CUSTOMER REPORTED RECEIVING A NEGATIVE HCG RESULT AT THE 3 MINUTE READ TIME BUT OBSERVED A FAINT LINE THAT DEVELOPED AT 4 MINUTES. THE TEST WAS REPEATED USING A SECOND FISHER - SURE-VUE HCG SERUM/URINE CASSETTE AND ANOTHER NEGATIVE HCG RESULT WAS RECEIVED AT THE 3 MINUTE READ TIME. A SERUM SAMPLE WAS THEN OBTAINED FROM THE PATIENT AND PRODUCED A POSITIVE HCG RESULT AT THE 5 MINUTE READ TIME USING A THIRD FISHER - SURE-VUE HCG SERUM/URINE CASSETTE. A SERUM QUANTITATIVE TEST WAS ALSO PERFORMED ON THE SAME DAY AND YIELDED AN HCG RESULT OF 47 MIU/ML. ON (B)(6) 2017, A SECOND SERUM QUANTITATIVE TEST WAS PERFORMED FOR THE PATIENT AND YIELDED AN HCG RESULT OF 83 MIU/ML.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6959724 ↗