MEDLINE MPH22025HCGRecalls & reported problems
Medline Industries, Inc. · TEST,HCG,PREGNANCY,COMBO,CASS,20/10 MIU · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is the Medline hCG Combo pregnancy test cassette, a visual urine test used to detect pregnancy. The 43 reports mostly describe the test reading positive when a patient is not pregnant, along with some false negatives and hard-to-read results. There are 5 injuries and no deaths. One open recall, started in August 2026, says the rapid tests can pick up very low hCG levels and produce false positives.
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
- 53
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 30884389191884), received between Jun 11, 2019 and Sep 30, 2026 — classified as 5 injuries, 48 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (37 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- False Positive Result37
- False Negative Result10
- Incorrect, Inadequate or Imprecise Result or Readings6
- Display Difficult to Read1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information10
- No Known Impact Or Consequence To Patient8
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026False Positive Result
It was reported that "We have now come across 2 boxes of medline branded pregnancy tests that have given us false positives on now 4 patients. We had instances where we told the patient they were pregnant and they were not."
Patient problems: Insufficient Information
MAUDE report 50947043 ↗MalfunctionSep 30, 2026False Positive Result
It was reported that "We have now come across 2 boxes of medline branded pregnancy tests that have given us false positives on now 4 patients. We had instances where we told the patient they were pregnant and they were not."
Patient problems: Insufficient Information
MAUDE report 50947015 ↗MalfunctionSep 29, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935939 ↗MalfunctionSep 28, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924382 ↗MalfunctionSep 28, 2026False Negative Result
The report states, "Staff calling regarding false negative."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913609 ↗MalfunctionSep 25, 2026False Positive Result
It was reported that "The HCG combo pregnancy test cassette has generated a false positive test in our urgent care department in Palo Alto".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896474 ↗MalfunctionSep 22, 2026False Positive Result
It was reported that "The HCG combo pregnancy test cassette has generated a false positive test in our urgent care department in Palo Alto".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853542 ↗MalfunctionSep 22, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853401 ↗MalfunctionSep 18, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829178 ↗MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "THEY TRIED 4 OUT OF THE BOX, THEY DIDNT RUN AT ALL, IT DIDNT PRODUCE A CONTROL OR A POS OR NEG RESULT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808961 ↗MalfunctionSep 10, 2026Display Difficult to Read
It was reported that the "indicator line isn¿t always showing a solid line for non-pregnancy and can be faded."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713795 ↗MalfunctionSep 8, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678366 ↗MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677143 ↗MalfunctionAug 17, 2026False Negative Result
The customer reported an unknown number of false negative results when testing patients with the Medline hCG Combo Pregnancy Test Cassette. Three attempts have been made to obtain additional details; however, the customer has been unresponsive. No adverse health outcomes were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280799 ↗MalfunctionMay 13, 2026False Positive Result
THE DISTRIBUTOR REPORTED AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS WHEN TESTING WITH THE MEDLINE HCG COMBO PREGNANCY TEST CASSETTE. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS; HOWEVER THE CUSTOMER WAS UNRESPONSIVE. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166352 ↗MalfunctionApr 9, 2026False Positive Result
ACCORDING TO THE CUSTOMER CONTACT ON (B)(6) 2026, THERE WAS A "FALSE POSITIVE URINE HCG TEST." THE CUSTOMER REPORTED A "QUANTITATIVE SERUM HCG TEST WAS PERFORMED TO CONFIRM THE RESULTS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830110 ↗MalfunctionJan 13, 2026False Positive Result
THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 4 FALSE POSITIVE RESULTS WHILE USING MEDLINE HCG COMBO+ PREGNANCY TEST CASSETTES ON 4 PATIENTS. THE THIRD AND FOURTH PATIENTS WERE TESTED ON (B)(6) 2025 USING THE MEDLINE HCG COMBO CASSETTES, AND A FALSE POSITIVE RESULT WAS OBTAINED FOR EACH PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO NEGATIVE HEALTH OUTCOMES WERE REPORTED. MDR 2027969-2026-00008, 2027969-2026-00009, AND 2027969-2026-00010 FOR PATIENTS (B)(6) RESPECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063600 ↗MalfunctionJan 13, 2026False Positive Result
THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 4 FALSE POSITIVE RESULTS WHILE USING MEDLINE HCG COMBO+ PREGNANCY TEST CASSETTES ON 4 PATIENTS. THE FIRST PATIENT WAS TESTED ON (B)(6) 2025 USING THE MEDLINE HCG COMBO CASSETTE, AND A FALSE POSITIVE RESULT WAS OBTAINED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO NEGATIVE HEALTH OUTCOMES WERE REPORTED. MDR 2027969-2026-00009, 2027969-2026-00010, AND 2027969-2026-00011 FOR PATIENTS 2-4 RESPECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063591 ↗MalfunctionJan 13, 2026False Positive Result
THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 4 FALSE POSITIVE RESULTS WHILE USING MEDLINE HCG COMBO+ PREGNANCY TEST CASSETTES ON 4 PATIENTS. THE SECOND PATIENT WAS TESTED ON (B)(6) 2025 USING THE MEDLINE HCG COMBO CASSETTE, AND A FALSE POSITIVE RESULT WAS OBTAINED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO NEGATIVE HEALTH OUTCOMES WERE REPORTED. MDR 2027969-2026-00008, 2027969-2026-00010, AND 2027969-2026-00011 FOR PATIENTS (B)(6) RESPECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063589 ↗MalfunctionJan 13, 2026False Positive Result
THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED A TOTAL OF 4 FALSE POSITIVE RESULTS WHILE USING MEDLINE HCG COMBO+ PREGNANCY TEST CASSETTES ON 4 PATIENTS. THE THIRD AND FOURTH PATIENTS WERE TESTED ON (B)(6) 2025 USING THE MEDLINE HCG COMBO CASSETTES, AND A FALSE POSITIVE RESULT WAS OBTAINED FOR EACH PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. NO NEGATIVE HEALTH OUTCOMES WERE REPORTED. MDR 2027969-2026-00008, 2027969-2026-00009, AND 2027969-2026-00011 FOR PATIENTS (B)(6) RESPECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063587 ↗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 COMBO 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 23840591 ↗MalfunctionOct 24, 2025False Positive Result; False Positive Result
THE DISTRIBUTOR REPORTED A FALSE POSITIVE RESULT WHEN TESTING A PATIENT URINE SAMPLE WITH THE MEDLINE HCG COMBO+ PREGNANCY TEST CASSETTE. THE PATIENT WAS TESTED IN AN URGENT CARE FACILITY. A SERUM SAMPLE WAS COLLECTED AND SENT TO A LAB FOR QUANTITATIVE HCG TESTING. THE RESULT WAS NEGATIVE (QUANTITATIVE VALUE NOT PROVIDED). NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23381090 ↗MalfunctionOct 17, 2025False Positive Result; False Positive Result
THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED 5 FALSE POSITIVE HCG RESULTS WHILE USING MEDLINE HCG COMBO CASSETTES ON 4 PATIENTS. ALTHOUGH REQUESTED, IT IS UNCLEAR WHICH PATIENT EXPERIENCED 2 FALSE POSITIVE HCG RESULTS. NO ADVERSE HEALTH OUTCOMES WERE REPORTED FOR ALL PATIENTS. THE CUSTOMER REPORTED SOME OF THE PATIENTS HAD NO SEXUAL INTERCOURSE, HOWEVER NO FURTHER INFORMATION WAS PROVIDED. SEE MDRS 2027969-2025-00211, 2027969-2025-00212, AND 2027969-2025-00213 FOR PATIENTS 1-3 RESPECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327727 ↗MalfunctionOct 17, 2025False Positive Result; False Positive Result
THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED 5 FALSE POSITIVE HCG RESULTS WHILE USING MEDLINE HCG COMBO CASSETTES ON 4 PATIENTS. ALTHOUGH REQUESTED, IT IS UNCLEAR WHICH PATIENT EXPERIENCED 2 FALSE POSITIVE HCG RESULTS. NO ADVERSE HEALTH OUTCOMES WERE REPORTED FOR ALL PATIENTS. THE CUSTOMER REPORTED SOME OF THE PATIENTS HAD NO SEXUAL INTERCOURSE, HOWEVER NO FURTHER INFORMATION WAS PROVIDED. SEE MDRS 2027969-2025-00211, 2027969-2025-00212, AND 2027969-2025-00214 FOR PATIENTS 1,2, AND 4 RESPECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23326572 ↗MalfunctionOct 17, 2025False Positive Result; False Positive Result
THE DISTRIBUTOR REPORTED THAT A CUSTOMER RECEIVED 5 FALSE POSITIVE HCG RESULTS WHILE USING MEDLINE HCG COMBO CASSETTES ON 4 PATIENTS. ALTHOUGH REQUESTED, IT IS UNCLEAR WHICH PATIENT EXPERIENCED 2 FALSE POSITIVE HCG RESULTS. NO ADVERSE HEALTH OUTCOMES WERE REPORTED FOR ALL PATIENTS. THE CUSTOMER REPORTED SOME OF THE PATIENTS HAD NO SEXUAL INTERCOURSE, HOWEVER NO FURTHER INFORMATION WAS PROVIDED. SEE MDRS 2027969-2025-00211, 2027969-2025-00213, AND 2027969-2025-00214 FOR PATIENTS 1,3, AND 4 RESPECTIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325300 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.