Elecsys proBNP II Immunoassay 09315284190Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613336191521), received between Feb 14, 2023 and Mar 26, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Low Test 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 385 PG/ML. THE CLINICIAN QUESTIONED THE RESULT AND REQUESTED THAT THE SAMPLE BE REPEATED BECAUSE THE PATIENT'S RESULT IS TYPICALLY AROUND 10,000 PG/ML. THE REPEATED RESULT WAS 19265 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700473 ↗
• MalfunctionMar 10, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE NOT MATCHING THE PATIENT'S CLINICAL DIAGNOSIS WHEN TESTED WITH ELECSYS PROBNP G2 (PROBNP II) ASSAY ON A COBAS E801 ANALYTICAL UNIT. THE CUSTOMER INITIALLY TESTED THE SAMPLE ON A VITROS SYSTEM AND THE RESULT WAS BELOW DETECTABILITY. THE CUSTOMER TESTED THE SAMPLE ON AN E801 AND THE RESULT WAS ALSO BELOW DETECTABILITY. THE CUSTOMER THEN DILUTED THE SAMPLE AND TESTED IT AGAIN AND THE RESULT WAS THE SAME AS THE PREVIOUS ONE. THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY FOR RE-TESTING AND THE BNP RESULT WAS ABOUT 300 PG/ML. ON 05-MAR-2025, THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A 2ND E801 ANALYZER RESULTING IN A PROBNP II VALUE OF 5.00 PG/ML AND ACCOMPANIED BY A DATA FLAG. THE CUSTOMER SUSPECTED A GENETIC MUTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559941 ↗
• MalfunctionFeb 24, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS PROBNP G2 (PROBNP II) ASSAY ON A COBAS E801 ANALYTICAL UNIT THAT DID NOT MATCH THE PATIENT'S CONDITION. RESULT: 2257 PG/ML. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444986 ↗
• MalfunctionJan 9, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PROBNP II (PROBNP II) ON A COBAS E 801 ANALYTICAL UNIT. NOTE: THE UNIT OF MEASURE WAS NOT PROVIDED. THE INITIAL RESULT WAS 178. THE REPEAT RESULT WAS 3376.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114921 ↗
• MalfunctionSep 17, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROBNP II (PROBNP II) I RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE TWO PATIENT SAMPLES WITH DISCREPANT RESULTS: SAMPLE 1 THE INITIAL RESULT WAS 11367 PG/ML. THE REPEAT RESULT WAS 8047 PG/ML. SAMPLE 2 THE INITIAL RESULT WAS 16036 PG/ML. THE REPEAT RESULT WAS 11144 PG/ML. THE REPORTER STATED THAT ALL QC LEVELS WERE OUT OF THE >3 STANDARD DEVIATION RANGE, PROMPTING THE RERUN OF THE PATIENT SAMPLES. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237261 ↗
• MalfunctionSep 5, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II ASSAY RESULTS FOR SEVERAL PATIENT PLASMA SAMPLES ON A COBAS E 801 ANALYTICAL UNIT INSTRUMENT. THE CUSTOMER PROVIDED EXAMPLES OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES. THE DOCTOR QUESTIONED THE RESULTS AS THEY DID NOT FIT THE CLINICAL PICTURE OF THE PATIENTS. FOR PATIENT 1, THE INITIAL RESULT WAS 200 PG/ML . THE NEXT DAY, THE PATIENT HAD A RESULT OF 20000 PG/ML. THE EXACT DATE OF TESTING WAS NOT PROVIDED. FOR PATIENT 2, THE INITIAL RESULT WAS 1700 PG/ML . THE NEXT DAY, THE PATIENT HAD A RESULT OF APPROXIMATELY 5000 PG/ML. THE EXACT DATE OF TESTING WAS NOT PROVIDED. ON 11-AUG-2024, PATIENT 3 HAD INITIAL RESULT WAS 1776 PG/ML. THE NEXT DAY, A PLASMA TUBE FROM THE PATIENT GAVE A RESULT OF 2239 PG/ML AND A SERUM TUBE FROM THE PATIENT GAVE A RESULT OF 2363 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148435 ↗
• MalfunctionDec 15, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH ELECSYS PROBNP G2 (PROBNP II) STAT ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A COBAS PRO ANALYZER. SAMPLE 1: INITIAL RESULT: 1266 PG/ML. REPEAT RESULT: 34930 PG/ML (TESTED ON COBAS PRO). SAMPLE 2: INITIAL RESULT: <50 PG/ML. REPEAT RESULT: 751 PG/ML (TESTED ON COBAS PRO). SAMPLE 3: INITIAL RESULT: <50 PG/ML. REPEAT RESULT: 528 PG/ML (TESTED ON COBAS PRO). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AS THEY DID NOT MATCH THE PATIENTS' PREVIOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337040 ↗
• MalfunctionFeb 14, 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 THE ELECSYS PROBNP II IMMUNOASSAY VER. 2.1 ON A COBAS E 801 ANALYTICAL UNIT (SERIAL NUMBER(B)(4). THE SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF 18.3 PG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO MEDICAL PERSONNEL. THE RESULT WAS QUESTIONED SINCE IT DID NOT AGREE WITH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 5299 PG/ML, WHICH WAS DEEMED CORRECT AND MATCHED THE PATIENT'S CLINICAL PICTURE. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A PROBNP VALUE OF > 5000 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375795 ↗