Medline MPH12325HCGRecalls & reported problems

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20888277703572), received between Sep 9, 2026 and Sep 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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

Display or Visual Feedback Problem1
False Negative Result1
Missing Test Results1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Ectopic Pregnancy1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Missing Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954137 ↗
MalfunctionSep 25, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904314 ↗
MalfunctionSep 9, 2026False Negative Result
Patient problems: Ectopic Pregnancy
MAUDE report 50699092 ↗

Device details

UDI-DI	`20888277703572`
Brand	Medline
Model	MPH12325HCG
Company	Medline Industries, Inc.
Product code	JHI · Visual, pregnancy hCG, prescription use
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.

Other Visual, pregnancy hCG, prescription use devices

McKesson 5001
Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use
2 recalls165 reports
CARDINAL HEALTH B1077-23
Cardinal Health 200, LLC · Visual, pregnancy hCG, prescription use
1 recall149 reports
McKesson 5000
Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use
2 recalls90 reports
McKesson 5002
Mckesson Medical-Surgical Inc. · Visual, Pregnancy Hcg, Prescription Use
2 recalls33 reports
Sure-Vue 4581405021
Fisher Scientific Company L.L.C. · Visual, pregnancy hCG, prescription use
1 recall83 reports
Henry Schein 9004072
Henry Schein, Inc. · Visual, pregnancy hCG, prescription use
1 recall79 reports
AlereTM 92210
Alere San Diego, Inc. · Visual, Pregnancy Hcg, Prescription Use
2 recalls23 reports
MEDLINE MPH12025HCG
Medline Industries, Inc. · Visual, pregnancy hCG, prescription use
1 recall69 reports

All Visual, pregnancy hCG, prescription use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.