Elecsys proBNP II CalSet 09315292190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336191538), received between May 3, 2023 and May 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH MULTIPLE ASSAYS ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE CUSTOMER PROVIDED EXAMPLES OF DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS FT4 IV ASSAY AND A SECOND PATIENT SAMPLE TESTED WITH THE ELECSYS PROBNP II IMMUNOASSAY. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO UNITS OF MEASURE WERE PROVIDED. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN A FT4 VALUE OF 3 AND IT REPEATED AS 12. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF < 10 AND IT REPEATED AS 200. THE FT4 REAGENT LOT NUMBER WAS 586657 AND THE PROBNP REAGENT LOT NUMBER WAS 650156. THE REAGENT EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862488 ↗