Medline MPH11325HCGRecalls & reported problems

Medline Industries, Inc. · TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20888277703565), received between Oct 22, 2024 and Sep 8, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

False Negative Result1
False Positive Result1
Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 8, 2026False Positive Result
It was reported that "4 tests from this lot tested positive and we had to cancel procedures, but the blood pregnancy tests came back negative."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667919 ↗
InjuryOct 22, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings
ACCORDING TO THE CUSTOMER, "OVER THE COURSE OF A COUPLE MONTHS" THE PREGNANCY TESTS ARE "NOT WORKING", THE LINES ARE NOT APPEARING, THE LINES "APPEAR EITHER JUST ON THE VERY SIDE OF THE CASSETTE OR HALFWAY ACROSS" AND ARE RESULTING WITH "FALSE NEGATIVES".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20507445 ↗

Device details

UDI-DI	`20888277703565`
Brand	Medline
Model	MPH11325HCG
Company	Medline Industries, Inc.
Product code	LCX · KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
Class	Class 2
FDA submission	K043443
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 14, 2024

Device type (GMDN): Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.

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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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