Uric Acid ver.2 5171857190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630925124), received between Dec 13, 2024 and Sep 24, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888731 ↗
• MalfunctionMay 4, 2026Incorrect Measurement

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 5 PATIENTS' SAMPLES TESTED WITH URIC ACID VER.2 ASSAY ON A COBAS 8000 C702 MODULE. SAMPLE 1: INITIAL RESULT: 702.2 MMOL/L. REPEAT RESULT: 244.4 MMOL/L. SAMPLE 2: INITIAL RESULT: 683.9 MMOL/L. REPEAT RESULT: 242.9 MMOL/L. SAMPLE 3: INITIAL RESULT: 692.6 MMOL/L. REPEAT RESULT: 298.8 MMOL/L. SAMPLE 4: INITIAL RESULT: 681.7 MMOL/L. REPEAT RESULT: 229.4 MMOL/L. SAMPLE 5: INITIAL RESULT: 675.9 MMOL/L. REPEAT RESULT: 439.4 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' CLINICAL DIAGNOSIS, AND REPEATED THE SAMPLES AFTER REPLACING THE REAGENT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE RESULTS WITH THE LOWER VALUES WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073316 ↗
• MalfunctionSep 18, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE URIC ACID VER.2 RESULTS FROM THE COBAS 8000 C702 MODULE. THE CUSTOMER REPLACED THE REAGENT PACK AND PERFORMED REPEAT TESTING. SAMPLE (B)(6), INITIAL RESULT WAS 636 UMOL/L, AND THE REPEAT RESULT WAS 312 UMOL/L. SAMPLE (B)(6), INITIAL RESULT WAS 583 UMOL/L, AND THE REPEAT RESULT WAS 218 UMOL/L. SAMPLE (B)(6), INITIAL RESULT WAS 733 UMOL/L, AND THE REPEAT RESULT WAS 419 UMOL/L. SAMPLE (B)(6), INITIAL RESULT WAS 648 UMOL/L, AND THE REPEAT RESULT WAS 308 UMOL/L. SAMPLE (B)(6), INITIAL RESULT WAS 621 UMOL/L, AND THE REPEAT RESULT WAS 268 UMOL/L. SAMPLE (B)(6), INITIAL RESULT WAS 595 UMOL/L, AND THE REPEAT RESULT WAS 227 UMOL/L. SAMPLE (B)(6) INITIAL RESULT WAS 528 UMOL/L, AND THE REPEAT RESULT WAS 85 UMOL/L. SAMPLE (B)(6), INITIAL RESULT WAS 713 UMOL/L, AND THE REPEAT RESULT WAS 394 UMOL/L. SAMPLE (B)(6), INITIAL RESULT WAS 587 UMOL/L, AND THE REPEAT RESULT WAS 194 UMOL/L. SAMPLE (B)(6), INITIAL RESULT WAS 650 UMOL/L, AND THE REPEAT RESULT WAS 295 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082834 ↗
• MalfunctionDec 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE URIC ACID (UA2) RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 CORE UNIT INSTRUMENT. TWO SAMPLES FROM THE SAME PATIENT WERE TESTED WHERE ONE RESULT WAS 120 UMOL/L AND THE OTHER RESULT WAS <12 UMOL/L. THE INITIAL RESULT OF 120 UMOL/L WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE WAS REPEATED TWICE AND THE RESULT WAS <12 UMOL/L BOTH TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924999 ↗