Elecsys IgE II Immunoassay 4827031190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630922369), received between Jul 20, 2023 and Nov 11, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS IGE II IMMUNOASSAY ON A COBAS 6000 E601 MODULE. THE SAMPLE INITIALLY RESULTED IN AN IGE VALUE OF 1573 IU/ML. THE SAMPLE WAS DILUTED 1:20 AND REPEATED, RESULTING IN A VALUE OF > 50000 IU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526047 ↗
• MalfunctionMay 15, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGE II RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 0.931 IU/ML AND THE REPEAT RESULT WAS 589.9 IU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321624 ↗
• MalfunctionOct 6, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS IGE II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THE INITIAL RESULT WAS 405.1 NG/ML. THE REPEAT RESULT WAS 253.2 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887100 ↗
• MalfunctionAug 7, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGE II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL IGE RESULT WAS 134.5 IU/ML. THE SAMPLE WAS REPEATED AS THE INITIAL RESULT WAS OUTSIDE OF THE REFERENCE RANGE. THE REPEAT RESULT WAS 1.02 IU/ML AND THE SECOND REPEAT RESULT WAS 147.5 IU/ML. THE SECOND REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475403 ↗
• MalfunctionJul 20, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS IGE II ON A COBAS 6000 E601 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN IGE VALUE OF 0.195 UI/ML ACCOMPANIED BY A DATA FLAG INDICATING CARRYOVER. THERE WERE ONLY 3 TESTS REMAINING IN THE REAGENT PACK DURING THIS MEASUREMENT. THE SAMPLE WAS REPEATED, RESULTING IN AN IGE VALUE OF 958.2 UI/ML. THIS MEASUREMENT WAS PERFORMED USING A NEW REAGENT PACK. AN ADDITIONAL IGE VALUE OF < 0.100 UI/ML WITH A DATA FLAG WAS PROVIDED. IT WAS ASKED, BUT IT IS NOT KNOWN IF THIS IS AN ADDITIONAL REPEAT VALUE FROM THE COMPLAINED SAMPLE OR IF IT IS A RESULT OF A DIFFERENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362987 ↗