OSOM hCG Urine 50 Test Kit 101Recalls & reported problems

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00742860001017), received between Jan 8, 2025 and Jan 8, 2025 — classified as 1 injury.

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

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJan 8, 2025False Negative Result; False Negative Result
ON (B)(6) 2024, THE PATIENT'S FIRST MORNING URINE WAS TESTED WITH AN OSOM HCG URINE TEST, AND THE RESULT WAS NEGATIVE. NO SERUM QUANTITATIVE HCG WAS PERFORMED. ON THE SAME DAY, THE PATIENT HAD AN ABDOMINAL SURGICAL PROCEDURE. A MASS WAS DISCOVERED DURING THE PROCEDURE WHICH TURNED OUT TO BE A THIRD TRIMESTER PREGNANCY. THE SURGERY WAS HALTED, AND THE PATIENT WAS ADMITTED TO HOSPITAL. ADDITIONAL DETAILS OF THE EVENT (SUCH AS WHICH PROCEDURE THE PATIENT HAD, PATIENT WEIGHT, ETC.) WERE NOT PROVIDED. DETAILS REGARDING THE OUTCOME OF THE PATIENT OR THE PREGNANCY WERE ALSO NOT PROVIDED. THE CUSTOMER STATED THEY HAD BEEN USING THE SAME LOT FOR SOME TIME, AND THAT THEY ARE A HIGH-VOLUME FACILITY (APPROX. 50 HCG PER DAY). THE FACILITY REPORTED NO OTHER FALSE NEGATIVES HAD BEEN OBTAINED USING THIS LOT.
Patient problems: Insufficient Information
MAUDE report 21107248 ↗

Device details

UDI-DI	`00742860001017`
Brand	OSOM hCG Urine 50 Test Kit
Model	101
Company	Sekisui Diagnostics, LLC
Product code	JHI · Visual, pregnancy hCG, prescription use
Class	Class 2
FDA submission	K974159
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	Jun 30, 2026

Device type (GMDN): Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

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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.