ADVIA Chemistry CO2_c 10720780Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414000541), received between Nov 19, 2020 and Nov 19, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “High 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 18, 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.

• MalfunctionNov 19, 2020High Test Results; High Test Results

  MULTIPLE DISCORDANT, FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) PATIENT RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY 1800 INSTRUMENT USING REAGENT LOT 090. THE INITIAL RESULTS WERE REPORTED TO A PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CHEMISTRY 1800 INSTRUMENT AND THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULTS. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS CORRECTED RESULTS. THE CUSTOMER PROVIDED TWO EXAMPLES OF DISCORDANT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10871167 ↗