Sure-VueRecalls & reported problems across all models
Fisher Scientific Company L.L.C. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one Sure-Vue model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 184
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 4
We found 6 models of Sure-Vue by Fisher Scientific Company L.L.C. in the FDA's device registry (GUDID). Together they are named in 184 adverse event reports in the FDA's MAUDE database, received between May 22, 2017 and Feb 16, 2026 — classified as 8 injuries, 176 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (159 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Sure-Vue recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 20, 2026Open, 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 ↗
- Aug 20, 2026Open, 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 ↗
- Aug 20, 2026Open, 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 · names 2 of these models · Recall details · FDA record ↗
- Aug 20, 2026Open, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported Sure-Vue problems
Device problems
- False Positive Result159
- False Negative Result20
- Incorrect, Inadequate or Imprecise Result or Readings4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions139
- No Consequences Or Impact To Patient25
- Insufficient Information6
- No Information6
- No Known Impact Or Consequence To Patient4
- Anxiety2
- No Code Available2
Sure-Vue models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sure-Vue 4581405021Visual, pregnancy hCG, prescription use1 recall83 reports
- Sure-Vue 4581395021Visual, pregnancy hCG, prescription use1 recall45 reports
- Sure-Vue 4581425021Visual, pregnancy hCG, prescription use1 recall39 reports
- Sure-Vue 4581445021Visual, pregnancy hCG, prescription use1 recall10 reports
- Sure-Vue 4581415021Visual, pregnancy hCG, prescription use1 recall6 reports
- Sure-Vue 4581435021Visual, pregnancy hCG, prescription use1 recall1 report
Recent Sure-Vue adverse event reports
The 15 most recent reports across all models, 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 ↗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 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 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page