Elecsys proBNP II Immunoassay 09315268160Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336191569), received between Feb 6, 2023 and Jul 28, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 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.

• MalfunctionJul 28, 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 ELECSYS PROBNP II ON A COBAS E411 RACK ANALYZER. THE SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF 71.6 PG/ML. A DOCTOR QUESTIONED THE RESULT BECAUSE IT DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS REPEATED, RESULTING IN A PROBNP VALUE OF 4898 PG/ML. THE REPEAT VALUE WAS DEEMED CORRECT AND MATCHED THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636442 ↗
• MalfunctionJan 4, 2024Low Test Results; Insufficient Device Problem Information; Non Reproducible Results; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PROBNP II ON TWO COBAS E 601 MODULE ANALYZERS. IT WAS ASKED, BUT IT IS NOT KNOWN WHICH OF THE TWO ANALYZERS WAS USED FOR EACH MEASUREMENT. THE SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF < 36 PG/ML WHEN TESTED ON THE FIRST E601 ANALYZER. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SECOND E601 ANALYZER, RESULTING IN A PROBNP VALUE OF 8000 PG/ML. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445077 ↗
• MalfunctionDec 19, 2023High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLE THAT WAS AUTO-DILUTED ONBOARD WHILE TESTED WITH ELECSYS PROBNP G2 (PROBNP II) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER WHEN COMPARED TO AN E601 IMMUNOASSAY ANALYZER. INITIAL RESULT: 3600 PG/ML ACCOMPANIED BY A DATA FLAG AND DILUTED AS A 100X AUTO-DILUTION. THE RESULT WAS QUESTIONED BY THE PROVIDER AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE SAMPLE WAS THEN REPEATED ON E601 AND THE REPEAT RESULT WAS 970 PG/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULTS WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354461 ↗
• MalfunctionMay 4, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 5 PATIENTS' PLASMA SAMPLES TESTED WITH ELECSYS PROBNP G2 ASSAY ON A COBAS E411 IMMUNOANALYZER SERIAL NUMBER (B)(4). THE CUSTOMER STATED THAT THE PBNP SAMPLES WERE FLAGGED AS SHORT SAMPLES, BUT THE SAMPLE VOLUME APPEARED OK. SO THEY TESTED THE SAMPLES AGAIN IN HITACHI CUPS AND THE INITIAL RESULTS FOR SAMPLE 1, SAMPLE 2, SAMPLE 3, SAMPLE 4 AND SAMPLE 5 WERE ALL < 50 PG/ML. THE CUSTOMER QUESTIONED THE INTIAL RESULTS AND REPEATED THE SAMPLES. THE REPEAT RESULTS: SAMPLE 1: 7769 PG/ML. SAMPLE 2: 2117 PG/ML. SAMPLE 3: 7915 PG/ML. SAMPLE 4: 863.2 PG/ML. SAMPLE 5: 317.8 PG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868694 ↗
• MalfunctionFeb 6, 2023Incorrect Measurement; Low Test Results; Non Reproducible Results; Incorrect Measurement; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II VER.2.1 IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL PROBNP RESULT WAS 36.00 PG/ML WITH FLAG. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. THE CUSTOMER REPLACED THE REAGENT PACK PRIOR TO REPEATING THE SAMPLE AS THERE WERE ONLY A FEW TESTS LEFT ON THE INITIAL REAGENT PACK. THE SAMPLE WAS REPEATED 3 TIMES AND THE RESULTS WERE 3318 PG/ML, 3335 PG/ML, AND 3305 PG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT. BOTH PROBNP REAGENT PACKS' LOT NUMBERS WERE 64177200 AND THE EXPIRATION DATES ARE 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16307580 ↗