ISE Solution 2 20738069122Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 13, 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 04015630915088), received between Dec 19, 2023 and Dec 19, 2023 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Low Test 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.
MalfunctionDec 19, 2023Low Test Results; Low Test Results
THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 SODIUM RESULTS FROM THE COBAS INTEGRA 400 PLUS. ONE EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 132 MMOL/L AND A REPEAT RESULT FROM A DIFFERENT ANALYZER OF 139 MMOL/L. THE REPEAT RESULTS WERE BELIEVED CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18357460 ↗
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- Atellica CH hsCRP Calibrator 11099412Siemens Healthcare Diagnostics Inc. · Calibrator, multi-analyte mixture1 recall0 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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