Elecsys ?-CrossLaps/serum 07026960190Recalls & 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 04015630940141), received between May 14, 2024 and May 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Measurement” (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
- Incorrect Measurement1
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.
MalfunctionMay 14, 2024Incorrect Measurement; Incorrect Measurement
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS B-CROSSLAPS/SERUM (B-CROSSLAPS) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 CORE UNIT. ON (B)(6) 2024, THE INITIAL RESULT FROM THE ANALYZER WAS <10 PG/ML. THE FIRST REPEAT RESULT WAS CONSISTENT. THE REPORTER NOTED THAT THE PATIENT HAS OSTEOPOROSIS AND SECONDARY HYPERPARATHYROIDISM AND THAT HER OTHER BONE MARKERS (N-MID AND TP1NP) WERE BOTH WITHIN THE REFERENCE RANGE. THE REPORTER QUESTIONED THE INITIAL RESULT AND SENT THE PATIENT SAMPLE FOR FURTHER TESTING USING A DOMESTIC PLATFORM WITH CHEMILUMINESCENCE IMMUNOASSAY (CLIA) AS THE LABORATORY METHOD. ON (B)(6) 2024, THE SECOND REPEAT RESULT FROM THE DOMESTIC PLATFORM USING THE CLIA METHOD WAS 34 PG/ML (REFERENCE RANGE <1017 PG/ML).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19312618 ↗
Other COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE devices
- Elecsys Beta-CrossLaps/serum 09005781190Roche Diagnostics GmbH · COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE2 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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