Elecsys HE4 Assay 5950929190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630929641), received between Jan 18, 2022 and Dec 20, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Audible Prompt/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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Audible Prompt/Feedback Problem1
- High Test Results1
- Low Readings1
- Low Test Results1
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.
MalfunctionDec 20, 2023High Test Results; Audible Prompt/Feedback Problem; High Test Results; Audible Prompt/Feedback Problem
THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE PATIENT¿S CLINICAL PICTURE WHEN TESTED FOR ELECSYS HE4 (HE4) ON TWO COBAS E 601 MODULES. THE INITIAL RESULT FROM THE CUSTOMER'S E601 MODULE WAS 248 PMOL/L. THE PATIENT WAS TESTED FOR HE4 ON AN E601 MODULE AT A DIFFERENT HOSPITAL AND THE RESULT WAS 228.1 PMOL/L. THE PATIENT WAS TESTED BY A COMPETITOR METHOD AT A DIFFERENT HOSPITAL AND THE HE4 RESULT WAS 34.3 PMOL/L.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18367603 ↗MalfunctionJan 18, 2022Low Test Results; Low Readings; Low Test Results; Low Readings
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 8 PATIENT SAMPLES TESTED FOR ELECSYS HE4 ASSAY (HE4) ON A COBAS 8000 E 602 MODULE. THE QUESTIONABLE RESULTS WERE FROM ONE PARTICULAR REAGENT PACK. THE REPEAT RESULTS WERE FROM THE SAME LOT NUMBER BUT A DIFFERENT REAGENT PACK. REFER TO ATTACHED DATA FOR THE RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E602 MODULE SERIAL NUMBER WAS (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13284875 ↗
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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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