Uric Acid ver.2 3183807190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630919154), received between Apr 20, 2023 and Sep 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675833 ↗
• MalfunctionJun 18, 2024Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH URIC ACID VER.2 ON A COBAS 6000 C501 MODULE. THE FIRST SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.6 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 7.69 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.5 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 5.41 MG/DL. THE THIRD SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.5 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 5.03 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557771 ↗
• MalfunctionJul 25, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH UA2 (URIC ACID) ON A COBAS INTEGRA 400 PLUS SYSTEM. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST MEASUREMENT OF EACH SAMPLE WAS PERFORMED USING REAGENT LOT 693815. THE SECOND MEASUREMENT OF EACH SAMPLE WAS PERFORMED USING A SECOND PACK OF REAGENT LOT 693815. THE THIRD MEASUREMENT OF EACH SAMPLE WAS PERFORMED USING REAGENT LOT NUMBER 714189. SAMPLE 1 URIC ACID RESULTS: MEASUREMENT 1 = 0.76 MG/DL MEASUREMENT 2 = 0.71 MG/DL MEASUREMENT 3 = 6.05 MG/DL SAMPLE 2 URIC ACID RESULTS: MEASUREMENT 1 = 0.86 MG/DL MEASUREMENT 2 = 0.91 MG/DL MEASUREMENT 3 = 7.45 MG/DL SAMPLE 3 URIC ACID RESULTS: MEASUREMENT 1 = 0.46 MG/DL MEASUREMENT 2 = 0.43 MG/DL MEASUREMENT 3 = 3.93 MG/DL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390063 ↗
• MalfunctionJul 12, 2023Device Difficult to Setup or Prepare; Non Reproducible Results; Device Difficult to Setup or Prepare; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT URINE SAMPLES TESTED WITH UA2 (URIC ACID VER.2) ON A COBAS 4000 C311. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AS THE PATIENTS HAD "NORMAL" SERUM VALUES. PATIENT SAMPLE 1: THE SAMPLE INITIALLY RESULTED IN A UA2 VALUE OF 3.29 MG/DL. THE SAMPLE WAS REPEATED ON A COBAS C 501 MODULE, RESULTING IN A VALUE OF 31.72 MG/DL. PATIENT SAMPLE 2: THE SAMPLE INITIALLY RESULTED IN A UA2 VALUE OF 3.0 MG/DL. THE SAMPLE WAS REPEATED ON A COBAS C 501 MODULE, RESULTING IN A VALUE OF 32 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309412 ↗
• MalfunctionApr 20, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE UA2 URIC ACID VER.2 RESULTS FOR 1 PATIENT FROM 5 SAMPLES ON TWO COBAS 8000 COBAS C 502 MODULES, SERIAL NUMBERS (B)(6). THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER COMMUNICATED WITH THE DOCTOR AND THEY STATED THAT THE RESULTS DO NOT MATCH THE PATIENT'S CLINICAL STATUS AND AN INTERFERING SUBSTANCE IS SUSPECTED. ON (B)(6)2023, THE UA2 RESULT FROM ANALYZER 17E4-01 WAS 0.0 MG/DL. THE SAMPLE WAS REPEATED ON ANALYZER 17E4-02 AND THE RESULT WAS 0.0 MG/DL. A SECOND SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2023 ALSO RESULTED IN A UA VALUE OF 0.0 MG/DL ON ANALYZER 17E4-01. ON (B)(6) 2023, THE UA2 RESULTS FROM ANALYZER 17E4-01 WERE 0.1 MG/DL AND 0.1 MG/DL. THE SAMPLE WAS REPEATED ON ANALYZER 17E4-02 AND THE RESULT WAS 0.1 MG/DL. ON (B)(6) 2023, THE UA2 RESULT FROM ANALYZER 17E4-02 WAS 1.3 MG/DL. ON (B)(6) 2023, THE UA2 RESULT FROM ANALYZER 17E4-02 WAS 2.7 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781472 ↗