UreaBUN 4460715190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630920464), received between May 2, 2023 and Mar 11, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K972250); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE UREA/BUN RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE'S INITIAL TEST ONLY PRODUCED A DATA FLAG ON ANOTHER C 503 MODULE (MODULE 2). THE SAMPLE WAS REPEATED ON THE ALLEGED MODULE (MODULE 1), AND THE RESULT WAS 17 MG/DL. THE SAMPLE WAS REPEATED ON MODULE 2, AND THE RESULT WAS 134 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE RESULT DIDN'T CORRELATE WITH THE PATIENT'S CREATININE RESULT OF 3.6 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570204 ↗
• MalfunctionAug 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH UREA/BUN (UREAL) ASSAY ON A COBAS 4000 C311 STAND ALONE SYSTEM. INITIAL RESULT: 244 MG/DL (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 228 MG/DL (AUTO-REPEATED WITH DILUTION). 2ND REPEAT RESULT: 25 MG/DL. THE 2ND REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22707790 ↗
• MalfunctionApr 15, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR APPROXIMATELY SIX PATIENT SAMPLES TESTED WITH UREA/BUN ON A COBAS 8000 C 502 MODULE. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT BUN RESULTS. THE SAMPLE INITIALLY RESULTED IN A BUN VALUE OF 3 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A BUN VALUE OF 57 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838902 ↗
• MalfunctionJan 30, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS OF MULTIPLE PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS 6000 C (501) MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE TESTED FOR UREAL. THE INITIAL RESULT WAS 0 MG/DL. THE REPEAT RESULT WAS 55 MG/DL. "SOME" OF THE SAMPLES WERE ACCOMPANIED BY DATA FLAGS PROMPTING THE CUSTOMER TO REPEAT PATIENT SAMPLES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276893 ↗
• MalfunctionJan 22, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH UREAL ON A COBAS 4000 C311 STAND ALONE SYSTEM. HIGH RESULTS FROM THE SAMPLE DID NOT AGREE WITH THE PATIENT'S HISTORICAL VALUES, SO THE SAMPLE WAS REPEATED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A UREA VALUE OF 94.9 MG/DL. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 76.9 MG/DL AND 104.6 MG/DL. ADDITIONAL UREA VALUES OF 115.3 MG/DL, 88.8 MG/DL, AND 105 MG/DL WERE ALSO PROVIDED. IT WAS ASKED, BUT IT IS NOT KNOWN IF THESE VALUES WERE FROM THE SAME COMPLAINED SAMPLE, FROM A DIFFERENT SAMPLE, OR IF THESE VALUES WERE PROVIDED IN ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18554162 ↗
• MalfunctionMay 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE UREAL (UREA) RESULTS FOR EIGHT PATIENT SAMPLES FROM THE COBAS INTEGRA 400 PLUS SERIAL NUMBER (B)(6). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE REPEATED ON (B)(6) 2023 AFTER THE DOCTORS QUERIED THE RESULTS. SAMPLE (B)(6) INITIAL RESULT WAS 9.4 MMOL/L AND THE REPEAT RESULT WAS 5.09 MMOL/L. THE REPEAT RESULT IN A DIFFERENT LAB WAS 5.31 MMOL/L. SAMPLE (B)(6) INITIAL RESULT WAS 14.1 MMOL/L AND THE REPEAT RESULT WAS 6.98 MMOL/L. THE REPEAT RESULT FROM A DIFFERENT INSTRUMENT WAS 6.62 MMOL/L. SAMPLE (B)(6) INITIAL RESULT WAS 6.9 MMOL/L. THE REPEAT RESULTS WERE 2.9 MMOL/L AND 2.95 MMOL/L. SAMPLE (B)(6) INITIAL RESULT WAS 9.0 MMOL/L. THE REPEAT RESULTS WERE 4.48 MMOL/L AND 4.44 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852880 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972250. One submission often covers many models, so check the product and lot details in each record.

• Z-0688-2008 · Dec 3, 2007 · Terminated
  Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250