Elecsys AFP 09015124190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336172025), received between Jun 13, 2025 and Jul 11, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025High Test Results; Contamination /Decontamination Problem; Non Reproducible Results; High Test Results; Contamination /Decontamination Problem; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH ELECSYS ALPHA-FETOPROTEIN (AFP) ASSAY ON A COBAS 8000 E 801 ANALYZER. SAMPLE 1: INITIAL RESULT: 23.3 NG/ML. 1ST REPEAT RESULT: 2.5 NG/ML. 2ND REPEAT RESULT: 2.49 NG/ML. SAMPLE 2: INITIAL RESULT: 22.9 NG/ML. 1ST REPEAT RESULT: 2.79 NG/ML. 2ND REPEAT RESULT: 2.77 NG/ML. SAMPLE 3: INITIAL RESULT: 12.7 NG/ML. 1ST REPEAT RESULT: 1.7 NG/ML. 2ND REPEAT RESULT: 1.69 NG/ML. THE INITIAL RESULTS DID NOT MATCH THE PATIENTS' CLINICAL DIAGNOSIS, AND THE SAMPLES WERE REPEATED. THE 2ND REPEAT RESULTS WERE OBTAINED FROM ANOTHER E 801. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484085 ↗
• MalfunctionJun 13, 2025Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS ALPHA-FETOPROTEIN (AFP) ASSAY ON A COBAS PURE E402 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 11.9 IU/ML. 1ST REPEAT RESULT: 3.04 IU/ML. SAMPLE 2: INITIAL RESULT: 10.3 IU/ML. 1ST REPEAT RESULT: 1.18 IU/ML. SAMPLE 3: INITIAL RESULT: 20.2 IU/ML. 1ST REPEAT RESULT: 182.7 IU/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS FOR SAMPLE 1, SAMPLE 2, AND SAMPLE 3 AS THEY WERE HIGH, AND THE SAMPLES WERE THEN REPEATED FOR THE 1ST TIME ON AN E411). ON (B)(6) 2025, SAMPLE 1, SAMPLE 2, AND SAMPLE 3 WERE REPEATED AFTER REPLACING A NEW REAGENT PACK AND PERFORMING CALIBRATION ON THE E402. SAMPLE 1: 2ND REPEAT RESULT: 3.4 IU/ML (TESTED ON E402). 3RD REPEAT RESULT: 3.94 IU/ML (TESTED ON E411). SAMPLE 2: 2ND REPEAT RESULT: 1.57 IU/ML (TESTED ON E402). 3RD REPEAT RESULT: 1.38 IU/ML (TESTED ON E411). SAMPLE 3: 2ND REPEAT RESULT: 165 IU/ML (TESTED ON E402). 3RD REPEAT RESULT: 184.9 IU/ML (TESTED ON E411). ALSO, ON (B)(6) 2025, SAMPLE 4 WAS INITIALLY TESTED ON E402, RESULTING IN AN AFP VALUE OF 225 IU/ML. THE SAMPLE WAS REPEATED ON AN E411 USING ANOTHER REAGENT LOT NUMBER, AND THE REPEAT RESULT WAS 1.19 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201806 ↗