Elecsys AFP Assay 4481798190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630920716), received between Jul 25, 2018 and Aug 3, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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.

• MalfunctionAug 3, 2022High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR ELECSYS AFP ASSAY (AFP) ON A COBAS 8000 E 602 MODULE. THE RESULTS WERE BELIEVED TO BE TOO HIGH AS THE PATIENT HAS NO SIGNS OR SYMPTOMS OF ANY DISEASE; OTHER RESULTS (THYROID, OTHER TUMOR MARKERS) AND EXAMINATIONS (ROUTINE BLOOD AND B-ULTRASONIC) SHOWED NO ABNORMALITIES. THE PATIENT IS HEALTHY AND HAS NO OTHER KNOWN DISEASE. THE PATIENT DOES NOT TAKE ANY MEDICATION AND DOES NOT RECEIVE ANY TREATMENT. IT IS NOT KNOWN IF THE PATIENT TAKES ANY DIETARY SUPPLEMENTS. THE INITIAL RESULT FROM THE E602 MODULE WAS 30956 NG/ML. THE SAMPLE WAS REPEATED WITH A RESULT OF 36091 NG/ML. ANOTHER RESULT FROM THE E602 MODULE WAS ALLEGEDLY 33639 NG/ML. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE AFP RESULTS WERE REPORTED TO BE SIMILAR USING OTHER METHODS. THE E602 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15159577 ↗
• MalfunctionJan 17, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY THE COBAS E 411 IMMUNOASSAY ANALYZER. THE EVENTS INVOLVED A TOTAL OF 2 PATIENTS WITH LOW RESULTS FOR THE ELECSYS AFP ASSAY. THE PATIENTS' AGES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' GENDERS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED, BUT WERE NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 8256689 ↗
• MalfunctionAug 28, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR AN UNSPECIFIED NUMBER OF SAMPLES FROM THE SAME PATIENT TESTED FOR THE ELECSYS AFP ASSAY ON A COBAS 6000 E 601 MODULE. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THE CUSTOMER STATED THAT OVER A TWO YEAR PERIOD, MULTIPLE SAMPLES FROM THE PATIENT RECOVERED HIGH AFP RESULTS RANGING BETWEEN 761 AND 1028 NG/ML WHEN TESTED WITH MULTIPLE LOTS OF THE ROCHE ASSAY. WHEN TESTED WITH THE ABBOTT AND BECKMAN COULTER ASSAYS, THE PATIENT ALSO HAD HIGH VALUES. THE WAKO AND SIEMENS IMMULITE PLATFORMS, HOWEVER, YIELDED RESULTS FROM THE PATIENT WHICH WERE WITHIN THEIR RESPECTIVE NORMAL REFERENCE RANGES. THE CUSTOMER DOES NOT KNOW WHICH VALUES ARE CORRECT, BUT BELIEVES THE HIGH VALUES TO BE IN ERROR. THE CUSTOMER SUSPECTS THAT SAMPLES FROM THE PATIENT CONTAIN AN INTERFERENT TO A COMPONENT OF THE ROCHE AFP ASSAY. THE PATIENT WAS NOT TAKING HIGH LEVELS OF BIOTIN. THE CUSTOMER PROVIDED DATA FOR TWO SPECIFIC SAMPLES FROM THE PATIENT. NO SPECIFIC TESTING DATES WERE PROVIDED FOR THE TWO SAMPLES. THE CUSTOMER STATED THAT THE PATIENT WAS LAST TESTED 2 TO 3 MONTHS PRIOR TO (B)(6) 2018. THE FIRST SAMPLE RESULTED AS 761 NG/ML WHEN TESTED ON THE E601 AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822221 ↗
• MalfunctionJul 25, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT ELECSYS AFP ASSAY RESULTS FOR TWO SAMPLES FROM ONE PATIENT ON A COBAS 8000 E 602 MODULE, SERIAL NUMBER (B)(6). FOR SAMPLE 1, THE INITIAL AFP RESULT WAS 9.6 NG/ML. THE RESULT WAS 3.1 NG/ML WITH THE WAKO METHOD. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS. ON (B)(6) 2018, A NEW SAMPLE WAS COLLECTED AND THE INITIAL AFP RESULT WAS 7.7 NG/ML. THE AFP RESULT WAS 2.2 NG/ML WITH THE WAKO METHOD. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SAMPLE THAT WAS COLLECTED ON (B)(6) 2018 WAS PROVIDED FOR INVESTIGATION. THE AFP RESULTS WERE 8.93 NG/ML AND 8.49 NG/ML FROM A COBAS 6000 E 601 MODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 7719092 ↗