Elecsys Rubella IgG Immunoassay 4618793160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630939251), received between Sep 29, 2021 and Sep 29, 2021 — 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

Recent adverse event reports

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

• MalfunctionSep 29, 2021High Test Results; High Test Results

  THERE WAS A COMPLAINT OF DISCREPANT ELECSYS RUBELLA IGG IMMUNOASSAY (IGG) RESULTS FOR 1 PATIENT TESTED WITH A COBAS 8000 E602 MODULE. THE DISCREPANT RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT¿S SAMPLE 1 INITIAL IGG RESULT IN JULY 2021 WAS 6.66 UI/ML AND THE SAMPLE RECEIVED AN ELECSYS RUBELLA IGM IMMUNOASSAY (IGM) RESULT OF 0.2 COI. BOTH INITIAL IGG AND IGM RESULTS WERE NEGATIVE. THE PATIENT'S SAMPLE 2 WAS RUN TWICE ON (B)(6) 2021. THE FIRST IGG RESULT WAS 13.08 UI/ML AND THE SAMPLE RECEIVED AN IGM RESULT OF 0.2 COI. THE REPEAT IGG RESULT WAS 12.59 UI/ML ON (B)(6) 2021. BOTH IGG RESULTS WERE POSITIVE WHILE THE IGM RESULT WAS NEGATIVE. THE PATIENT¿S SAMPLE 3 WAS RUN ON (B)(6) 2021 WITH AN IGG RESULT OF 21.67 UI/ML AND AN IGM RESULT OF 0.2 COI; AND REPEATED ON A DIASORIN ANALYZER WHERE IT GOT NEGATIVE RESULTS FOR BOTH IGG AND IGM. THE COBAS RESULTS WERE POSITIVE FOR IGG AND NEGATIVE FOR IGM. THE PATIENT HAD A RUBELLA IGG RESULT OF 20.93 UI/ML ON (B)(6) 2021. IT IS UNKNOWN IF THE PATIENT IS VACCINATED FOR RUBELLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546663 ↗