Elecsys SHBG 3052001160Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630939305), received between Sep 25, 2024 and Sep 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (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
- Low Test Results1
- Non Reproducible Results1
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.
MalfunctionSep 25, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results
THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS SHBG RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS THE REPORTER SUSPECTED THE INITIAL RESULT TO BE TOO LOW. THE INITIAL RESULT WAS 0.92 NMOL/L. THE FIRST REPEAT RESULT WAS 30.93 NMOL/L. THE SECOND REPEAT RESULT WAS 27.37 NMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20304679 ↗
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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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