Atellica CH UPro 11097524Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414595870), received between Dec 13, 2019 and Dec 13, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2019Low Test Results; Low Test Results

  TWO DISCORDANT, FALSELY DEPRESSED TOTAL PROTEIN_2 (URINE) (UPRO) RESULTS WERE OBTAINED USING ATELLICA CH 930 MODULE. THE INITIAL RESULTS WERE PERFORMED USING AN ALTERNATE NON-SIEMENS METHOD. THE INITIAL RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING SIEMENS ATELLICA CH 930 MODULE (BOTH SAMPLES) AND DIMENSION EXL (SAMPLE ID (B)(6) FOR TROUBLESHOOTING PURPOSE ONLY). THE REPEAT RESULTS FROM ATELLICA CH 930 MODULE WERE CONSIDERED DISCORDANT AND WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED UPRO RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9469432 ↗