UreaBUN 5171873190Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04015630925131), received between Nov 7, 2022 and Oct 15, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR UREA/BUN ON A COBAS 8000 C702 MODULE. PATIENT 1 INITIAL RESULT WAS 3.6 MG/DL. ON (B)(6) 2025, THE REPEAT RESULT WAS 13.2 MG/DL. PATIENT 2 INITIAL RESULT WAS 1.4 MG/DL. ON (B)(6) 2025, THE REPEAT RESULT WAS 34.7 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293546 ↗
• MalfunctionMar 26, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE UREA/BUN RESULT FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 15 MG/DL, AND THE REPEAT RESULTS FROM ANOTHER COBAS 8000 WERE 1 MG/DL AND 58 MG/DL. THE INITIAL RESULT WAS DEEMED TO BE INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697052 ↗
• MalfunctionJan 23, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE UREA/BUN RESULTS FROM THE COBAS 8000 C702 MODULE. SAMPLE 1 INITIAL RESULT WAS 9.06 MMOL/L THE REPEAT RESULTS WERE 35.84 MMOL/L AND 35.72 MMOL/L. ON (B)(6) 2024, SAMPLE 2 INITIAL RESULT WAS 0.85 MMOL/L. THE REPEAT RESULTS WERE 14.61 MMOL/L AND 14.67 MMOL/L. THE FINAL REPEAT RESULTS WERE BELIEVED CORRECT AND WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217740 ↗
• MalfunctionDec 3, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE UREA/BUN (UREAL) RESULTS FROM URINE PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS C 701 MODULE. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1 THE INITIAL RESULT WAS 4.31 G/L. THE REPEAT RESULT WAS 8.67 G/L. SAMPLE 2 THE INITIAL RESULT WAS 0.32 G/L. THE REPEAT RESULT WAS 7.74 G/L. SAMPLE 3 THE INITIAL RESULT WAS 6.54 G/L. THE REPEAT RESULT WAS 0.49 G/L. THE REPORTER ASSUMES THE "WORST-CASE RESULTS" WERE INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832431 ↗
• MalfunctionJul 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 AND UREAL UREA/BUN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THIS MEDWATCH WILL COVER UREA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP2 RESULTS. FOR SAMPLE 1, THE INITIAL ALP RESULT WAS 9 U/L. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 144 U/L. FOR SAMPLE 2, THE INITIAL UREA RESULT WAS 0.5 MMOL/L. THE RESULT WAS LOWER THAN THE MEASURING RANGE WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 11.6 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840320 ↗
• MalfunctionAug 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE UREAL UREA/BUN AND CRPL3 C-REACTIVE PROTEIN GEN.3 RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. ON (B)(6) 2023, THE INITIAL UREAL RESULT FROM LINE B FOR SAMPLE 1 WAS 0.6 MMOL/L. THE REPEAT RESULT FROM LINE B WAS 20.0 MMOL/L. (B)(6) 2023, THE SAMPLE WAS REPEATED ON LINE A AND THE RESULT WAS 19.9 MMOL/L. ON (B)(6) 2023, SAMPLE 2 HAD AN INITIAL CRP4 RESULT OF 0.01 MG/DL. THE REPEAT RESULT WAS 0.34 MG/L. ON (B)(6) 2023, SAMPLE 3 HAD AN INITIAL UREAL RESULT OF 0.8 MMOL/L. THE REPEAT RESULT WAS 11.5 MMOL/L. CLARIFICATION ON WHICH LINES SAMPLES 2 AND 3 WERE RUN ON WAS NOT PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663171 ↗
• MalfunctionApr 25, 2023Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH UREA (UREAL) ASSAY ON A COBAS 8000 C702 MODULE SERIAL NUMBER 22G7-01. ON (B)(6) 2023: INITIAL RESULT: 42.4 MMOL/L > TEST (WITH A DATA FLAG). 1ST RERUN RESULT: 1.0 MMOL/L (THE SAMPLE WAS AUTOMATICALLY RERUN BY THE SYSTEM). 2ND RERUN RESULT: 41.5 MMOL/L (WITH NO DATA FLAG AND WAS TESTED WITH DILUTION). THIS RESULT WAS BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808264 ↗
• MalfunctionNov 7, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE UREAL (UREA/BUN) ASSAY ON A COBAS 8000 C 702 MODULE. THE SAMPLE INITIALLY RESULTED IN A VALUE OF 136.9 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN VALUES OF 27.2 MG/DL AND 27.4 MG/DL. IT IS UNKNOWN IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE UREAL REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748640 ↗

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