Bicarbonate liquid 3289923190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630919352), received between Nov 22, 2023 and Sep 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH BICARBONATE LIQUID ON A COBAS 6000 C501 MODULE. IT IS ALLEGED THAT THE PATIENT'S SAMPLES CONTAIN AN INTERFERING FACTOR AGAINST A COMPONENT OF THE BICARBONATE ASSAY. THE FIRST SAMPLE FROM THE PATIENT RESULTED IN BICARBONATE VALUES OF 7.1 MMOL/L AND 7.1 MMOL/L. A RE-COLLECTION OF THE PATIENT WAS REQUESTED. A SECOND SAMPLE (PLASMA) WAS COLLECTED FROM THE PATIENT AND TESTED ON (B)(6) 2025, RESULTING IN BICARBONATE VALUES OF 2.9 MMOL/L AND 2.3 MMOL/L. THIS SAME PLASMA SAMPLE WAS REPEATED ON AN UNKNOWN BLOOD GAS ANALYZER, RESULTING IN A BICARBONATE VALUE OF 22.6 MMOL/L. THE WHOLE BLOOD TUBE FROM THE SAME COLLECTION WAS ALSO TESTED ON THE BLOOD GAS ANALYZER, RESULTING IN A BICARBONATE VALUE OF 24.4 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955113 ↗
• MalfunctionNov 22, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR FOUR SAMPLES FROM THE SAME PATIENT TESTED WITH CO2-L (BICARBONATE) ON A COBAS 8000 COBAS C 502 MODULE. THE RESULTS OBTAINED FOR THE PATIENT DID NOT FIT THE PATIENT'S DIAGNOSIS OF ACIDOSIS. THE FIRST SAMPLE RESULTED IN A BICARBONATE VALUE OF 4 MMOL/L ON (B)(6) 2023. THE SECOND SAMPLE RESULTED IN A BICARBONATE VALUE OF 4 MMOL/L ON (B)(6) 2023. THE THIRD SAMPLE RESULTED IN A BICARBONATE VALUE OF 4 MMOL/L ON (B)(6) 2023. THE FOURTH SAMPLE RESULTED IN A BICARBONATE VALUE OF 6.1 MMOL/L ON (B)(6) 2023. ON AN UNKNOWN DATE, A SAMPLE FROM THE PATIENT WAS TESTED ON AN UNKNOWN BLOOD GAS ANALYZER, RESULTING IN THE FOLLOWING VALUES: PH = 7.35, PACO2 = 49 (NO UNITS PROVIDED), PAO2 = 88 (NO UNITS PROVIDED), BICARBONATE = 26 MMOL/L, LACTATE = 2.1 (NO UNITS PROVIDED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194372 ↗