Elecsys BRAHMS PCT 08828679190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613336166642), received between Feb 28, 2023 and Sep 28, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918910 ↗
• MalfunctionMar 30, 2026High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE ELECSYS BRAHMS PCT (PROCALCITONIN) RESULTS FOR ONE PATIENT SAMPLE TESTED ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. THE PROCALCITONIN RESULTS ARE INCONSISTENT WITH THE PATIENT'S CLINICAL STATUS, OTHER TEST RESULTS, AND THE PATIENT'S BACKGROUND. PRIOR TO UNDERGOING DIALYSIS, A SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED ON THE CUSTOMER'S E801 ANALYZER, RESULTING IN A PROCALCITONIN VALUE OF > 100 NG/ML. THIS SAMPLE HAD A CRP VALUE OF 3.23 MG/DL AND A WHITE BLOOD CELL COUNT OF 6602/UL, SO THERE WERE NO SIGNS OF INFECTION IN THE PATIENT. THE DOCTOR QUESTIONED THE PROCALCITONIN VALUE. THE SAMPLE WAS DILUTED TIMES 5 AND REPEATED ON THE CUSTOMER'S E801 ANALYZER, RESULTING IN A RAW PROCALCITONIN VALUE OF 16.2 NG/ML. THE FINAL VALUE WHEN ACCOUNTING FOR THE DILUTION FACTOR IS 81.0 NG/ML. THE SAMPLE (B)(6) 2026. THE REPEAT PROCALCITONIN RESULT WAS > 100 NG/ML. THE SAMPLE WAS DILUTED 1:5 AND REPEATED ON THIS ANALYZER, RESULTING IN A VALUE OF 79.5 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731819 ↗
• MalfunctionMar 11, 2026Incorrect Measurement; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS BRAHMS PCT RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 0.69 NG/ML. THE REPEAT RESULT WAS 0.05 NG/ML, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE SAMPLE WAS REPEATED AFTER THERE WAS A QC FAILURE FOR ELECSYS BRAHMS PCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570434 ↗
• MalfunctionJul 30, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS BRAHMS PCT (PCT) ON A COBAS E 402 ANALYTICAL UNIT. THE PATIENT WAS TESTED DAILY WITH RESULTS CONSISTENTLY AROUND 2 NG/ML (EXAMPLES PROVIDED WERE 1.89 NG/ML AND 2.11 NG/ML). THE RESULTS WERE "ALWAYS REPEATABLE." THE FOLLOWING SPECIFIC RESULTS WERE PROVIDED: ON (B)(6) 2025, THE RESULT WAS 2.22 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.49 NG/ML. ON (B)(6) 2025, THE RESULT WAS 1.94 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.08 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.18 NG/ML. ON (B)(6) 2025, THE RESULT WAS 1.87 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.09 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.09 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.08 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.21 NG/ML. ON (B)(6) 2025, THE RESULT WAS 1.91 NG/ML. THE PATIENT HAD BEEN INITIALLY TESTED BY A MINDRAY INSTRUMENT, WHICH PRODUCED SIMILAR RESULTS. A SAMPLE FROM THE PATIENT WAS TESTED AT AN EXTERNAL LABORATORY USING THE VIDAS METHOD, AND THE RESULT WAS ALSO "POSITIVE" (1.27 NG/ML). THE PCT RESULTS ARE IN QUESTION AS NO OTHER TEST RESULTS SUGGEST SEPSIS, THE PATIENT IS WELL WITH NO FEVER, AND THE CRP RESULT WAS "NEGATIVE." THE CUSTOMER SUSPEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663228 ↗
• MalfunctionJun 13, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS BRAHMS PCT RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.6 NG/ML, AND THE REPEAT RESULT ON ANOTHER E801 MODULE WAS 2.48 NG/ML. THE INITIAL RESULT WAS REPEATED AFTER THE CUSTOMER EXPERIENCED SOME QC ISSUES AND PERFORMED A PATIENT COMPARISON. THE CUSTOMER IS UNSURE WHICH RESULT IS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201818 ↗
• MalfunctionSep 1, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROCALCITONIN V2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 CORE UNIT. ON (B)(6) 2023, THE INITIAL RESULT WAS GREATER THAN 100 NG/ML. THE SAMPLE WAS REPEATED AND GAVE A RESULT OF GREATER THAN 100 NG/ML. ON (B)(6) 2023, A 1:3 DILUTION WAS MADE FROM THE INITIAL REFRIGERATED SAMPLE AND THE RESULT WAS 45 NG/ML. THE REFRIGERATED ORIGINAL SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 48.4 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671494 ↗
• MalfunctionFeb 28, 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 BRAHMS PCT ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A PCT VALUE OF 0.16 NG/ML. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED. THE SAMPLE WAS REPEATED RESULTING IN A PCT VALUE OF 28.9 NG/ML. A NEW SAMPLE DRAW OF THE PATIENT RESULTED IN A PCT VALUE OF 27.3 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454548 ↗