MEDLINE MPH11025HCGRecalls & reported problems
Medline Industries, Inc. · TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Medline hCG urine pregnancy test strip is used to visually check for pregnancy. Reports mostly describe results that were positive when the patient was not pregnant, including on cloudy or bloody urine samples; some describe missed positives and hard-to-read results. There are 51 reports, 4 injuries and no deaths. One open recall, started in August 2026, says the tests may pick up very low hCG levels and give a false positive.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 30884389191877), received between Jul 18, 2017 and Sep 30, 2026 — classified as 4 injuries, 57 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (38 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.
Reports received per month
Recalls naming this device
- 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-3273-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- False Positive Result38
- Incorrect, Inadequate or Imprecise Result or Readings12
- False Negative Result9
- Unable to Obtain Readings2
- Failure to Obtain Sample1
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- Insufficient Information8
- No Information2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951533 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936780 ↗MalfunctionSep 25, 2026Unable to Obtain Readings; Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897798 ↗MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "Multiple patients per day that immediately at 4mins, they begin to see a faint positive line."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889358 ↗MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885758 ↗MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "Multiple patients per day that immediately at 4mins, they begin to see a faint positive line. They will begin to keep count of how many patients per day, they are needing to run a 2nd pregnancy test."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871212 ↗MalfunctionSep 22, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857562 ↗MalfunctionSep 20, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834751 ↗MalfunctionSep 19, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833652 ↗MalfunctionSep 18, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829456 ↗MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that false positive/negative.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801193 ↗MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "this has been going on for the last 2-3 months and it¿s not every strip, nurses are saying that its "hit and miss".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754640 ↗MalfunctionSep 11, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741610 ↗MalfunctionSep 10, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722936 ↗MalfunctionApr 20, 2026False Positive Result
THE CUSTOMER REPORTED THREE FALSE POSITIVE RESULTS WHEN TESTING A PATIENT URINE SAMPLE WITH THE MEDLINE HCG PREGNANCY TEST STRIP. THE URINE SAMPLE WAS DESCRIBED AS CLOUDY AND SLIGHTLY CONCENTRATED, AND WAS ALLOWED TO SETTLE FOR 5 MINUTES PRIOR TO TESTING. THE SAMPLE WAS TESTED A TOTAL OF 5 TIMES, YIELDING 3 POSITIVE RESULTS AND 2 NEGATIVE RESULTS. A SERUM SAMPLE WAS COLLECTED AND SENT TO THE LAB FOR TESTING, AND YIELDED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT THERE WAS NO NEGATIVE IMPACT TO THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928478 ↗MalfunctionApr 20, 2026False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE MEDLINE HCG PREGNANCY TEST STRIP. A SERUM SAMPLE WAS COLLECTED AND SENT TO THE LAB FOR CONFIRMATORY TESTING, WHICH YIELDED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT THERE WAS NO NEGATIVE IMPACT TO THE PATIENT DUE TO THE FALSE POSITIVE RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928165 ↗MalfunctionSep 16, 2025False Positive Result; False Positive Result
THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS FOR 2 PATIENTS WHILE USING MEDLINE HCG URINE DIPSTICKS. THE CUSTOMER REPORTED THE SECOND PATIENT PRESENTED FOR "ON AND OFF BLEEDING" AFTER UNDERGOING A MEDICAL ABORTION PROCEDURE ON AN UNSPECIFIED DATE. THE PATIENT PROVIDED A URINE SAMPLE WHICH APPEARED BLOODY, HOWEVER NO PRECIPITATES WERE OBSERVED. THE SAMPLE WAS TESTED AND YIELDED A POSITIVE HCG RESULT. AN ADDITIONAL TEST WAS PERFORMED USING A DEVICE FROM THE SAME LOT AND AN ADDITIONAL HCG RESULT WAS OBTAINED. A CONFIRMATORY STAT BETA HCG TEST WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE EMDR 2027969-2025-00195 FOR THE FIRST PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23067464 ↗MalfunctionSep 16, 2025False Positive Result; False Positive Result
THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE HCG RESULTS FOR 2 PATIENTS WHILE USING MEDLINE HCG URINE DIPSTICKS. THE CUSTOMER REPORTED THE FIRST PATIENT PRESENTED FOR PREGNANCY WITH AN IUD ALREADY IMPLANTED. THE PATIENT PROVIDED A URINE SAMPLE WHICH WAS TESTED AND YIELDED A POSITIVE HCG RESULT. AN ADDITIONAL TEST WAS PERFORMED USING A DEVICE FROM THE SAME LOT AND AN ADDITIONAL HCG RESULT WAS OBTAINED. STAFF OFFERED TO REMOVE THE IUD AND PERFORM CONFIRMATORY BETA HCG TESTING, HOWEVER THE PATIENT DECLINE. THE PATIENT PRESENTED FOR A FOLLOW UP APPOINTMENT AND TESTING WITH A DEVICE FROM A DIFFERENT LOT YIELDED A NEGATIVE HCG RESULT. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE EMDR 2027969-2025-00196 FOR THE SECOND PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066918 ↗InjuryAug 22, 2025False Negative Result; False Negative Result
ACCORDING TO THE CUSTOMER, THE PREGNANCY TEST PRODUCED A FALSE NEGATIVE THAT WAS CONFIRMED WITH BLOODWORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22877431 ↗InjuryAug 22, 2025False Negative Result; False Negative Result
ACCORDING TO THE CUSTOMER, THE PREGNANCY TEST PRODUCED A FALSE NEGATIVE THAT WAS CONFIRMED WITH BLOODWORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873382 ↗MalfunctionMar 27, 2025False Positive Result; False Positive Result
THE DISTRIBUTOR REPORTED TWO FALSE POSITIVE RESULTS WHEN TESTING PATIENT SAMPLES USING THE MEDLINE HCG PREGNANCY TEST STRIP. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710696 ↗MalfunctionMar 5, 2025False Positive Result; False Positive Result
THE DISTRIBUTOR REPORTED 3 FALSE POSITIVE RESULTS WHEN TESTING AN UNKNOWN NUMBER OF PATIENTS USING THE MEDLINE HCG PREGNANCY TEST STRIP. THE CUSTOMER STATED THAT BLOODWORK WAS PERFORMED WITH NEGATIVE RESULTS. NO PATIENT DETAILS WERE PROVIDED, AND THE CUSTOMER STATED THAT THEY ARE NOT ABLE TO PROVIDE ANY FURTHER INFORMATION. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21530014 ↗InjurySep 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ACCORDING TO THE FACILITY ON (B)(6) 2024, "THE PATIENT HAD THEIR URINE SAMPLE RESULT POSITIVE AFTER BEING TESTED WITH A STRIP FROM THE SAME LOT #."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20291937 ↗InjurySep 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ACCORDING TO THE FACILITY ON (B)(6), "THE PATIENT'S URINE SAMPLE WAS TESTED 3 TIMES WITH THIS TEST STRIP. THE FIRST TEST WAS POSITIVE (2 LINES PRESENT) AND THE FOLLOWING TWO TESTS WERE NEGATIVE (ONE LINE PRESENT).".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20291468 ↗MalfunctionSep 11, 2024False Positive Result; False Positive Result
THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE HCG RESULT FOR 2 PATIENTS WHILE USING THE MEDLINE HCG URINE DIPSTICK TESTS. BOTH PATIENTS PRESENTED FOR PREGNANCY TESTING PRIOR TO UNDERGOING AN UNKNOWN NON-EMERGENT PROCEDURE. THE SECOND PATIENT'S URINE SAMPLE WAS COLLECTED ON 1JUL2024 AT 11:57AM. THE DIPSTICK WAS SUBMERGED FOR 5 SECONDS, THE RESULTS WERE READ AT 3 MINUTES, AND A FALSE POSITIVE HCG RESULT WAS OBTAINED. AS A RESULT, THE UNSPECIFIED PROCEDURE WAS CANCELLED, AND PATIENT WAS DISCHARGED HOME. A CONFIRMATORY SERUM HCG TEST WAS PERFORMED WHICH YIELDED A NEGATIVE RESULT. NO ADVERSE EVENT REPORTED. NO FURTHER INFORMATION PROVIDED. SEE MDR 2027969-2024-00164 FOR DETAILS REGARDING THE FIRST PATIENT.
Patient problems: Insufficient Information
MAUDE report 20192704 ↗
Other Visual, pregnancy hCG, prescription use devices
- McKesson 5001Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls165 reports
- CARDINAL HEALTH B1077-23Cardinal Health 200, LLC · Visual, pregnancy hCG, prescription use1 recall149 reports
- McKesson 5000Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls90 reports
- McKesson 5002Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls33 reports
- Sure-Vue 4581405021Fisher Scientific Company L.L.C. · Visual, pregnancy hCG, prescription use1 recall83 reports
- Henry Schein 9004072Henry Schein, Inc. · Visual, pregnancy hCG, prescription use1 recall79 reports
- AlereTM 92210Alere San Diego, Inc. · Visual, Pregnancy Hcg, Prescription Use2 recalls23 reports
- MEDLINE MPH12025HCGMedline Industries, Inc. · Visual, pregnancy hCG, prescription use1 recall69 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 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