Elecsys AFP 07026706190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630939909), received between Jun 5, 2025 and Dec 16, 2025 — classified as 2 malfunctions.

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 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.

• MalfunctionDec 16, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS AFP RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 1063 NG/ML. THE REPEAT RESULT AFTER 1:10 DILUTION WAS 12,100 NG/ML, ACCOMPANIED BY A DATA FLAG. A SECOND REPEAT RESULT AFTER 1:100 DILUTION WAS 121,000 NG/ML, ACCOMPANIED BY A DATA FLAG. A THIRD REPEAT RESULT AFTER 1:400 DILUTION WAS 484,000 NG/ML, ACCOMPANIED BY A DATA FLAG. A FOURTH REPEAT RESULT AFTER A MANUAL 1:10 DILUTION, AND THEN A 1:400 DILUTION ON THE INSTRUMENT, WAS 410,480 NG/ML. THE SAMPLE WAS REPEATED AFTER THE DOCTOR QUESTIONED IT. THE PATIENT HAD PREVIOUS RESULTS IN JULY THAT WERE EXTREMELY HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816117 ↗
• MalfunctionJun 5, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS NOT MATCHING THE PATIENT'S CLINICAL PICTURE FOR 1 PATIENT SAMPLE WHEN TESTED WITH ELECSYS ALPHA 1-FETOPROTEIN (AFP) ASSAY ON A COBAS E801 ANALYTICAL UNIT. INITIAL RESULT: 91.3 NG/ML. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND REPEATED THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. AFP RESULT ON WAKO CHEMILUMINESCENCE: 2.7 NG/ML, AND THIS RESULT WAS CONSIDERED NORMAL (REFERENCE RANGE: 0-7 NG/ML). AFP-L3/AFP: <0.5 % (REFERENCE RANGE: 0-9.99). PIVKA RESULT ON FUJI CHEMILUMINESCENCE ANALYZER (FUJIREBIO LUMIPULSE G1200): 22 MAU/ML (REFERENCE RANGE: 0-40 MAU/ML). THE PATIENT'S MAGNETIC RESONANCE IMAGING (MRI) EXAMINATION SHOWED NO ABNORMALITY. THE CUSTOMER BELIEVED THAT THE WAKO RESULT WAS CORRECT. THE CUSTOMER SUSPECTED AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148851 ↗