Elecsys BRAHMS PCT 08828644190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336166635), received between Jan 2, 2026 and Sep 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026High Test Results

  The initial reporter received a questionable Elecsys BRAHMS PCT assay result for one patient sample tested on the cobas 6000 e601 module. Initial analysis of the patient sample yielded 2.4 ng/mL. Repeat analysis yielded 0.09 ng/mL.The repeat result was reported, as the patient's previous result was 0.41 ng/mL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865648 ↗
• MalfunctionJan 2, 2026Incorrect Measurement; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS BRAHMS PCT RESULTS FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS >100 NG/ML. THE PHYSICIAN REQUESTED MANUAL DILUTION, AND THE CUSTOMER PERFORMED A 1:4 MANUAL DILUTION. THE RESULT WAS 15 NG/ML (X4=60 NG/ML). THE CUSTOMER PERFORMED ANOTHER 1:2 MANUAL DILUTION OF THE ORIGINAL SAMPLE, PRODUCING A RESULT OF 52 NG/ML. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942961 ↗