Elecsys Rubella IgM 07027796190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630940257), received between Oct 28, 2021 and Jul 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE ELECSYS RUBELLA IGM RESULTS FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 0.501 COI (NON-REACTIVE). THE CUSTOMER REPEATED THE SAMPLE WITH ANOTHER METHODOLOGY (ELFA), AND THE RESULT WAS 1.318 COI (REACTIVE). THE SAMPLE WAS REPEATED VIA CLIA METHODOLOGY, AND THE RESULTS WERE 3.83 COI AND 3.77 COI (REACTIVE). ON (B)(6) 2025, THE REPEAT RESULT WAS 0.577 COI (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554783 ↗
• MalfunctionSep 30, 2024False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE RUBELLA IGM ELECSYS RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS E 801 MODULE. THE REPORTER WAS VALIDATING THE ASSAY AND USED THE PATIENT SAMPLE AS AN INTERNAL QC. THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY THAT USES ENZYME-LINKED FLUORESCENCE ASSAY (ELFA) AND CHEMILUMINESCENCE IMMUNOASSAY (CLIA) LABORATORY METHODS. SAMPLE 1 ON (B)(6) 2024: THE INITIAL RESULT FROM THE MODULE WAS 0.746 CUT-OFF INDEX COI (NON-REACTIVE). ON (B)(6) 2024: THE REPEAT RESULT FROM THE ELFA LABORATORY METHOD WAS 3.39 INDEX (REACTIVE). THE REPEAT RESULT FROM THE CLIA LABORATORY METHOD WAS 8.04 INDEX (REACTIVE). SAMPLE 2 ON (B)(6) 2024: THE INITIAL RESULT FROM THE MODULE WAS 0.740 COI (NON-REACTIVE). THE REPEAT RESULT FROM THE ELFA LABORATORY METHOD WAS 3.60 INDEX (REACTIVE). THE REPEAT RESULT FROM THE CLIA LABORATORY METHOD WAS 8.12 INDEX (REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332493 ↗
• MalfunctionJun 6, 2022False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FALSE-NEGATIVE RUBELLA IGM ELECSYS RESULT FROM COBAS E 801 MODULE SERIAL NUMBER (B)(4). THE RESULT WAS 0.643 (NON-REACTIVE). THE PATIENT WAS ALSO TESTED ON A VIDAS INSTRUMENT AND THE RESULT WAS POSITIVE. THE SAME SAMPLE WAS ALSO TESTED ON COBAS E601 INSTRUMENT AND THE RESULT WAS NON-REACTIVE. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602905 ↗
• MalfunctionOct 28, 2021False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS RUBELLA IGM IMMUNOASSAY RESULT FROM COBAS E801 MODULE SERIAL NUMBER (B)(4). ON (B)(6) 2021, THE ELECSYS RUBELLA IGM RESULT WAS 0.599 COI (NON-REACTIVE). ON (B)(6) 2021, THE ELECSYS RUBELLA IGM RESULT WAS 0.598 COI (NON-REACTIVE). ON (B)(6) 2021, THE ELECSYS RUBELLA IGM RESULT WAS 0.617 COI (NON-REACTIVE). ON (B)(6)2021, THE RESULT FROM ANOTHER LABORATORY BY ELISA METHOD WAS POSITIVE. ALL RESULTS WERE FROM THE SAME PATIENT SAMPLE. IT WAS NOT KNOWN IF ANY QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712203 ↗