ICON 25 hCG 43025Recalls & reported problems

Beckman Coulter, Inc. · Icon 25 HCG, Box of 25 Tests · Class 2

Data updated Oct 16, 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.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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 16, 2026.

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-3272-2026 · Root cause: Device Design · Recall details · FDA record ↗

Device details

UDI-DI	`15099590776886`
Brand	ICON 25 hCG
Model	43025
Company	Beckman Coulter, Inc.
Product code	JHI · Visual, Pregnancy Hcg, Prescription Use
Class	Class 2
FDA submission	K993065
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2023

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

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McKesson 5000
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Sure-Vue 4581405021
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1 recall83 reports
McKesson 5002
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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
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MEDLINE MPH12025HCG
Medline Industries, Inc. · Visual, pregnancy hCG, prescription use
1 recall69 reports

All Visual, Pregnancy Hcg, Prescription Use devices →

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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