Uric Acid ver.2 08058750190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336121580), received between Apr 10, 2023 and Apr 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (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 16, 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.

• MalfunctionApr 10, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR NINE PATIENT SAMPLES TESTED WITH UA2 URIC ACID VER.2 ON COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE FIRST SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.5 MG/DL AND IT REPEATED AS 3.12 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.7 MG/DL AND IT REPEATED AS 5.89 MG/DL. THE THIRD SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 1.6 MG/DL AND IT REPEATED AS 5.06 MG/DL. THE FOURTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.4 MG/DL AND IT REPEATED AS 4.13 MG/DL. THE FIFTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.4 MG/DL AND IT REPEATED AS 3.63 MG/DL. THE SIXTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.7 MG/DL AND IT REPEATED AS 4.81 MG/DL. THE SEVENTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 1.1 MG/DL AND IT REPEATED AS 5.48 MG/DL. THE EIGHTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 2.4 MG/DL AND IT REPEATED AS 4.2 MG/DL. THE NINTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.8 MG/DL AND IT REPEATED AS 4.2 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708534 ↗