Icon 395097Recalls & reported problems
Beckman Coulter, Inc. · Icon 20 HCG, Box of 25 Tests · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 15099590625948), received between Dec 31, 2024 and Dec 31, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Output 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
Most reported problems
Device problems
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 31, 2024Output Problem; Output Problem
THE CUSTOMER REPORTED THAT THE ICON 20 HCG TESTS FOR LOT 034C11 GENERATED FALSE NEGATIVE RESULTS FOR TWO PATIENTS. THE CUSTOMER STATED THEY FOLLOWED THE TESTING PROCEDURE WHEN A FALSE NEGATIVE RESULT WAS OBTAINED FOR TWO PATIENTS. ONE PATIENT CONFIRMED THE PREGNANCY BY USING AN ALTERNATE METHOD THE NEXT DAY WITH NO DELAY OR IMPACT TO TREATMENT. THE SECOND PATIENT REPORTED HAVING RIGHT LOWER QUADRANT PAIN FOR SOME TIME AND SUSPECTED A PREGNANCY. ON (B)(6) 2024, THE ICON 20 HCG TEST WAS PERFORMED AND YIELDED A FALSE NEGATIVE FOR THE PRESENCE OF HCG, THE ACTION PLAN FOR TREATMENT SHIFTED FOCUS FROM PREGNANCY TO ABDOMINAL PAIN. ON (B)(6) 2024, THE PATIENT RETURNED PRESENTING THE SAME ONGOING SYMPTOMS, BLOOD WAS DRAWN AND THE BLOOD TEST CONFIRMED THE PRESENCE OF BETA-HCG AND THE PATIENT'S PREGNANCY. THERE WAS NO REPORT OF MEDICAL INTERVENTION REQUIRED AS RESULTS OF THE CHANGE IN PATIENT TREATMENT AND NO IMPACT TO THE PREGNANCY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21050440 ↗
Other Visual, Pregnancy Hcg, Prescription Use devices
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- 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 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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