Elecsys Testosterone II 05200067160Recalls & reported problems
Roche Diagnostics GmbH · Class 1
- 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 04015630939312), received between Aug 28, 2023 and Aug 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
- 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.
MalfunctionAug 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS TESTOSTERONE II ASSAY (TESTOSTERONE II) ON A COBAS 8000 COBAS E602 ANALYZER WHEN COMPARED TO THE LIQUID CHROMATOGRAPHY¿MASS SPECTROMETRY (LCMS/MS) METHOD AT A DIFFERENT FACILITY. INITIAL RESULT: 196 NG/DL (E602 MODULE). REPEAT RESULT: 308 NG/DL (LCMS/MS METHOD). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17637655 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.