Elecsys HCG CalSet 3302652190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
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 04015630919406), received between Jun 21, 2024 and Jun 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible 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
- 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.
MalfunctionJun 21, 2024Non Reproducible Results; Non Reproducible Results
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULTS FOR 2 PATIENT SERUM SAMPLES ON A COBAS 6000 E601 MODULE. THE DOCTOR QUESTIONED THE INITIAL RESULTS WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLES. FOR SAMPLE 1, THE INITIAL HCG RESULT WAS 62.44 MIU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E601 ANALYZER AND THE RESULT WAS <0.1 MIU/ML. FOR SAMPLE 2, THE INITIAL HCG RESULT WAS 126768 MIU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E601 ANALYZER AND THE RESULT WAS 67000 MIU/ML. CLARIFICATION ON IF ONE OF THE RESULTS WAS ACCOMPANIED BY A DATA FLAG WAS NOT PROVIDED. THE REPEAT RESULTS WERE DEEMED CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583379 ↗
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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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