MEDLINE MPH12025HCGRecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 30888277191871), received between Nov 10, 2017 and Sep 28, 2026 — classified as 5 injuries, 64 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (34 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Missing Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923508 ↗
• MalfunctionSep 28, 2026False Positive Result

  It was reported that "they have had four false positive pregnancy tests."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913088 ↗
• MalfunctionSep 25, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904148 ↗
• MalfunctionSep 25, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "THE TESTS WERE NOT PASSING INTERNAL QC, THE BACKGROUND WAS NOT COMING OUT CLEAR ENOUGH TO BE READ, LEADING TO INVALID TEST READINGS" and "TESTS WOULD NOT PROVIDE INFORMATION AFTER 5 MINUTES OF USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899030 ↗
• MalfunctionSep 23, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875946 ↗
• MalfunctionSep 22, 2026False Positive Result

  It was reported that "when administering test to patient the test show faintly positive for two tests in a row."

  Patient problems: Insufficient Information

  MAUDE report 50856721 ↗
• MalfunctionSep 21, 2026False Positive Result; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847581 ↗
• MalfunctionSep 21, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840228 ↗
• MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838920 ↗
• MalfunctionSep 16, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787239 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the patient had three positive home pregnancy tests and they performed a UPT in the office, waited 5 minutes and the result was negative. They tried another test, and after 5 minutes, it showed a faint line that only some could see.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716004 ↗
• MalfunctionSep 10, 2026False Positive Result

  It was reported that "2 false positive pregnancy tests out of this box."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714900 ↗
• MalfunctionSep 9, 2026False Negative Result

  It was reported that "Which showed a Negative result, but blood work proved positive."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690610 ↗
• MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that ¿(b)(6) is concerned about the pregnancy test with lot number HCG2022015. She has got three faintly positive.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689505 ↗
• MalfunctionMay 8, 2026False Negative Result

  THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED TWO FALSE NEGATIVE HCG RESULTS WHILE USING MEDLINE HCG PREGNANCY TEST CASSETTES. THE PATIENT PRESENTED AFTER RECEIVING A POSITIVE HOME URINE PREGNANCY HCG TEST. THE PATIENT'S URINE WAS TESTED IN OFFICE WHICH YIELDED 2 NEGATIVE HCG RESULTS. A CONFIRMATORY HCG BLOOD TEST WAS PERFORMED WHICH YIELDED A POSITIVE HCG TEST. THE CUSTOMER REPORTED QUALITY CONTROL TESTING WAS PERFORMED WHICH ALSO YIELDED A FALSE NEGATIVE HCG RESULT. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. AS A RESULT OF THE NEGATIVE TEST RESULT, THE PATIENT NOW UNDERGOES SERIAL HCG LAB WORK WEEKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131220 ↗
• MalfunctionDec 18, 2025False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WHEN TESTING PATIENTS WITH THE MEDLINE HCG PREGNANCY TEST CASSETTE. PATIENTS WERE BEING SCREENED PRIOR TO PROCEDURES. THE PROCEDURES WERE DELAYED UNTIL BLOODWORK COULD BE PERFORMED TO CONFIRM THE PATIENTS WERE NOT PREGNANT. NO ADVERSE OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840543 ↗
• MalfunctionAug 8, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING FAINT FALSE POSITIVE HCG RESULTS WHILE USING FOUR BOXES OF MEDLINE HCG PREGNANCY TEST CASSETTES. THE CUSTOMER REPORTED TESTING PATIENT URINE SAMPLES WITH MEDLINE HCG TEST CASSETTES DURING THE SECOND/THIRD WEEK OF MAY IN 2025. IT WAS REPORTED THAT FAINT POSITIVE RESULTS WERE OBTAINED, AND THE CONTROL LINES WOULD APPEAR AT 3-5 MINUTES. ADDITIONALLY, THE "BACKGROUND WAS NEVER FULLY CLEAR (WHITE), SO CONTROL LINE WAS HARD TO SEE, OR AN INCOMPLETE LINE WOULD APPEAR ALONG WITH A POSITIVE LINE." THE NUMBER OF FALSE POSITIVE RESULTS OR PATIENTS INVOLVED WAS NOT PROVIDED. HOWEVER, THE CUSTOMER INDICATED 3-4 HCG TESTS HAD TO BE USED TO CONFIRM THE RESULTS. SOME OF THE FAINT POSITIVE RESULTS WERE OBTAINED ON PATIENTS WHO WERE NOT PREGNANT. CONFIRMATORY HCG QUANTITATIVE TESTING WAS ORDERED IN SOME INSTANCES WHICH RESULTED NEGATIVE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. PLEASE NOTE THE FOLLOWING FROM THE PACKAGE INSERT: WAIT FOR THE RED LINES(S) TO APPEAR. READ THE RESULTS AT 3-4 MINUTES. DO NOT INTERPRET RESULTS AFTER THE APPROPRIATE READ TIME. POSITIVE: TWO DISTINCT RED LINES APPEAR. IT IS IMPORTANT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22759554 ↗
• MalfunctionJul 17, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED SIX FALSE POSITIVE RESULTS WHEN TESTING A PATIENT WITH THE MEDLINE HCG PREGNANCY TEST CASSETTE. THE PATIENT WAS BEING SCREENED FOR PREGNANCY PRIOR TO A COLONOSCOPY. THE PATIENT PROVIDED A URINE SAMPLE THAT WAS TESTED A TOTAL OF THREE TIMES, EACH TIME WITH A POSITIVE RESULT. A SECOND URINE SAMPLE WAS PROVIDED AND TESTED THREE TIMES, AGAIN YIELDING A POSITIVE RESULT EACH TIME. A SERUM SAMPLE WAS TESTED IN THE LAB WITH A NEGATIVE RESULT. THE COLOSCOPY WAS DELAYED BY SEVERAL HOURS DUE TO THE POSITIVE RESULTS. NO ADVERSE HEALTH OUTCOMES WERE REPORTED AS A RESULT OF THE DELAY. THE PATIENT RETURNED THREE DAYS LATER AND PROVIDED ANOTHER SERUM SAMPLE, WHICH WAS TESTED IN THE LAB AND YIELDED A NEGATIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22536115 ↗
• MalfunctionMay 1, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THEIR FACILITY RECEIVED SEVERAL FALSE POSITIVE HCG RESULTS USING MEDLINE HCG URINE CASSETTES ON 5 DIFFERENT PATIENTS. THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFICS AS TO WHEN THE FALSE POSITIVES OCCURRED, HOWEVER THEY INDICATED THE EVENTS OCCURRED SOMETIME BETWEEN 1APR2025 AND 14APR2025. EACH PATIENT PRESENTED FOR AN UNSPECIFIED REASON, AND ALL PATIENTS PROVIDED A FRESH URINE SAMPLE THAT WAS FREE OF VISIBLE CONTAMINANTS. THREE TO FOUR DROPS OF URINE WERE APPLIED TO THE CORRESPONDING DEVICE FOR EACH PATIENT. PLEASE NOTE, THE PACKAGE INSERT STATES "PLACE THE TEST CASSETTE ON A CLEAN AND LEVEL SURFACE. HOLD THE PIPETTE VERTICALLY AND TRANSFER 3 FULL DROPS OF URINE (APPROX. 100UL) TO THE SPECIMEN WELL (S) OF THE TEST CASSETTE, AND THEN START THE TIMER.". THE RESULTS WERE READ AT 3 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED FOR EACH OF THE FIVE PATIENTS. PATIENTS 2-5 WERE ALL RETESTED USING ANOTHER DEVICE FROM THE SAME LOT NUMBER AND FAINT POSITIVE HCG RESULTS WERE OBTAINED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER INDICATED NO NEGATIVE IMPACT OCCURRED AS A RESULT OF THE FALSE POSITIVE HCG RESULTS. THIS MDR IS FOR PATIENT 5. SEE MDR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944479 ↗
• MalfunctionMay 1, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THEIR FACILITY RECEIVED SEVERAL FALSE POSITIVE HCG RESULTS USING MEDLINE HCG URINE CASSETTES ON 5 DIFFERENT PATIENTS. THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFICS AS TO WHEN THE FALSE POSITIVES OCCURRED, HOWEVER THEY INDICATED THE EVENTS OCCURRED SOMETIME BETWEEN (B)(6) 2025. EACH PATIENT PRESENTED FOR AN UNSPECIFIED REASON, AND ALL PATIENTS PROVIDED A FRESH URINE SAMPLE THAT WAS FREE OF VISIBLE CONTAMINANTS. THREE TO FOUR DROPS OF URINE WERE APPLIED TO THE CORRESPONDING DEVICE FOR EACH PATIENT. PLEASE NOTE, THE PACKAGE INSERT STATES "PLACE THE TEST CASSETTE ON A CLEAN AND LEVEL SURFACE. HOLD THE PIPETTE VERTICALLY AND TRANSFER 3 FULL DROPS OF URINE (APPROX. 100UL) TO THE SPECIMEN WELL (S) OF THE TEST CASSETTE, AND THEN START THE TIMER.". THE RESULTS WERE READ AT 3 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED FOR EACH OF THE FIVE PATIENTS. PATIENTS 2-5 WERE ALL RETESTED USING ANOTHER DEVICE FROM THE SAME LOT NUMBER AND FAINT POSITIVE HCG RESULTS WERE OBTAINED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER INDICATED NO NEGATIVE IMPACT OCCURRED AS A RESULT OF THE FALSE POSITIVE HCG RESULTS. THIS MDR IS FOR PATIENT 4. SEE MDR 2027969-202

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944478 ↗
• MalfunctionMay 1, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THEIR FACILITY RECEIVED SEVERAL FALSE POSITIVE HCG RESULTS USING MEDLINE HCG URINE CASSETTES ON 5 DIFFERENT PATIENTS. THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFICS AS TO WHEN THE FALSE POSITIVES OCCURRED, HOWEVER THEY INDICATED THE EVENTS OCCURRED SOMETIME BETWEEN 1APR2025 AND 14APR2025. EACH PATIENT PRESENTED FOR AN UNSPECIFIED REASON, AND ALL PATIENTS PROVIDED A FRESH URINE SAMPLE THAT WAS FREE OF VISIBLE CONTAMINANTS. THREE TO FOUR DROPS OF URINE WERE APPLIED TO THE CORRESPONDING DEVICE FOR EACH PATIENT. PLEASE NOTE, THE PACKAGE INSERT STATES "PLACE THE TEST CASSETTE ON A CLEAN AND LEVEL SURFACE. HOLD THE PIPETTE VERTICALLY AND TRANSFER 3 FULL DROPS OF URINE (APPROX. 100UL) TO THE SPECIMEN WELL (S) OF THE TEST CASSETTE, AND THEN START THE TIMER.". THE RESULTS WERE READ AT 3 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED FOR EACH OF THE FIVE PATIENTS. PATIENTS 2-5 WERE ALL RETESTED USING ANOTHER DEVICE FROM THE SAME LOT NUMBER AND FAINT POSITIVE HCG RESULTS WERE OBTAINED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER INDICATED NO NEGATIVE IMPACT OCCURRED AS A RESULT OF THE FALSE POSITIVE HCG RESULTS. THIS MDR IS FOR PATIENT 3. SEE MDR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944435 ↗
• MalfunctionMay 1, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THEIR FACILITY RECEIVED SEVERAL FALSE POSITIVE HCG RESULTS USING MEDLINE HCG URINE CASSETTES ON 5 DIFFERENT PATIENTS. THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFICS AS TO WHEN THE FALSE POSITIVES OCCURRED, HOWEVER THEY INDICATED THE EVENTS OCCURRED SOMETIME BETWEEN (B)(6) 2025. EACH PATIENT PRESENTED FOR AN UNSPECIFIED REASON, AND ALL PATIENTS PROVIDED A FRESH URINE SAMPLE THAT WAS FREE OF VISIBLE CONTAMINANTS. THREE TO FOUR DROPS OF URINE WERE APPLIED TO THE CORRESPONDING DEVICE FOR EACH PATIENT. PLEASE NOTE, THE PACKAGE INSERT STATES "PLACE THE TEST CASSETTE ON A CLEAN AND LEVEL SURFACE. HOLD THE PIPETTE VERTICALLY AND TRANSFER 3 FULL DROPS OF URINE (APPROX. 100UL) TO THE SPECIMEN WELL (S) OF THE TEST CASSETTE, AND THEN START THE TIMER.". THE RESULTS WERE READ AT 3 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED FOR EACH OF THE FIVE PATIENTS. PATIENTS 2-5 WERE ALL RETESTED USING ANOTHER DEVICE FROM THE SAME LOT NUMBER AND FAINT POSITIVE HCG RESULTS WERE OBTAINED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER INDICATED NO NEGATIVE IMPACT OCCURRED AS A RESULT OF THE FALSE POSITIVE HCG RESULTS. THIS MDR IS FOR PATIENT 2. SEE MDR 2027969-202

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944313 ↗
• MalfunctionMay 1, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THEIR FACILITY RECEIVED SEVERAL FALSE POSITIVE HCG RESULTS USING MEDLINE HCG URINE CASSETTES ON 5 DIFFERENT PATIENTS. THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFICS AS TO WHEN THE FALSE POSITIVES OCCURRED, HOWEVER THEY INDICATED THE EVENTS OCCURRED SOMETIME BETWEEN 1APR2025 AND 14APR2025. EACH PATIENT PRESENTED FOR AN UNSPECIFIED REASON, AND ALL PATIENTS PROVIDED A FRESH URINE SAMPLE THAT WAS FREE OF VISIBLE CONTAMINANTS. THREE TO FOUR DROPS OF URINE WERE APPLIED TO THE CORRESPONDING DEVICE FOR EACH PATIENT. PLEASE NOTE, THE PACKAGE INSERT STATES "PLACE THE TEST CASSETTE ON A CLEAN AND LEVEL SURFACE. HOLD THE PIPETTE VERTICALLY AND TRANSFER 3 FULL DROPS OF URINE (APPROX. 100UL) TO THE SPECIMEN WELL (S) OF THE TEST CASSETTE, AND THEN START THE TIMER.". THE RESULTS WERE READ AT 3 MINUTES AND A POSITIVE HCG RESULT WAS OBTAINED FOR EACH OF THE FIVE PATIENTS. CONFIRMATORY HCG TESTING WAS PERFORMED AT AN EXTERNAL FACILITY FOR PATIENT 1 ((B)(6)) WHICH YIELDED A NEGATIVE HCG RESULT. NO ADVERSE EVENT WAS REPORTED. SEE MDR 2027969-2025-00116, 2027969-2025-00117, 2027969-2025-00118, AND 2027969-2025-00119 FOR PATIENTS 2-5 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944239 ↗
• MalfunctionFeb 26, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE USING MEDLINE HCG URINE CASSETTE TESTS FOR 3 PATIENTS. THE THIRD PATIENT WAS TESTED ON (B)(6) 2025 AND THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2025-00053 AND 2027969-2025-00054 FOR PATIENTS 1 AND 2 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471104 ↗
• MalfunctionFeb 26, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A TOTAL OF 3 FALSE POSITIVE HCG RESULTS WHILE USING MEDLINE HCG URINE CASSETTE TESTS FOR 3 PATIENTS. THE SECOND PATIENT WAS TESTED ON (B)(6) 2025 AND THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED. SEE MDR 2027969-2025-00053 AND 2027969-2025-00055 FOR PATIENTS 1 AND 3 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471043 ↗