Elecsys DHEA-S 3000087122Recalls & reported problems
Roche Diagnostics GmbH · Class 1
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 04015630917372), received between Jan 5, 2023 and Jun 3, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (2 reports).
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
- High Test Results2
- Non Reproducible 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.
MalfunctionJun 3, 2025High Test Results; High Test Results
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS DHEA-S RESULT FROM THE COBAS E 602 MODULE. THE INITIAL RESULT WAS > 1000 G/DL, AND THE REPEAT RESULT WAS > 1000 G/DL. THE SAMPLE WAS REPEATED ON A NON-ROCHE DEVICE WITH A RESULT OF 301.07 G/DL. THE SAMPLE WAS REPEATED ON ANOTHER NON-ROCHE DEVICE WITH A RESULT OF 212.502 G/DL. THE INITIAL RESULT WAS QUESTIONED BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND WAS NOT RELEASED OUTSIDE OF THE LABORATORY. THE RESULTS OF 301.07 G/DL AND 212.502 G/DL ARE DEEMED TO BE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22131214 ↗MalfunctionJan 5, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results
THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS 6000 E 601 MODULE. TWO SAMPLES WERE DRAWN AT THE SAME TIME INTO 2 PRIMARY SAMPLE TUBES. THE RESULTS FROM THE FIRST SAMPLE TUBE: 393.4 UG/DL, 254.8 UG/DL, AND 249.5 UG/DL. THE RESULTS FROM THE 2ND SAMPLE TUBE: 251.3 UG/DL, 380.9 UG/DL AND 261.8 UG/DL.. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DHEA-S REAGENT LOT NUMBER WAS 626134 WITH AN EXPIRATION DATE OF 30-SEP-2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16101301 ↗
Other RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) devices
- ARCHITECT 8K27-25Abbott GmbH · RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)1 recall0 reports
- Elecsys DHEA-S 07027192190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)12 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 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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