Mycophenolic Acid 4357213190Recalls & 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 04015630997381), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “High 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.
Most reported problems
Device problems
- High 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.
MalfunctionJul 22, 2022High Test Results; High Test Results
THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH MPA MYCOPHENOLIC ACID ON A COBAS 6000 C (501) MODULE (SERIAL NUMBER (B)(4). THE SAMPLE VALUE DID NOT CORRESPOND TO THE PATIENT'S CONDITION. THE SAMPLE RESULTED IN A MYCOPHENOLIC ACID VALUE OF 2.37 UG/ML WHEN TESTED ON THE C501 ANALYZER. THE VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT'S DOCTOR. THE VALUE DID NOT AGREE WITH THE PATIENT'S CONDITION. THE SAMPLE WAS SENT TO A SECOND SITE WHERE IT WAS TESTED USING AN UNKNOWN METHOD ON A SIEMENS ANALYZER AND THE RESULT WAS SIMILAR TO THE ONE OBTAINED ON THE C501 ANALYZER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15089564 ↗
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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