Bicarbonate Liquid 08057494190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613336121146), received between Jun 1, 2023 and Sep 28, 2026 — classified as 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914632 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717073 ↗
• MalfunctionJun 1, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER QUESTIONED THE RESULTS OF 1 PATIENT SAMPLE TESTED FOR BICARBONATE LIQUID (CO2-L) ON A C503 INSTRUMENT. THE INITIAL RESULT WAS 2.59 MMOL/L. AN ADDITIONAL RESULT OF < 2 MMOL/L WAS ALSO PROVIDED. A ½ DILUTION WAS PERFORMED AND THE RESULT WAS 4.73 MMOL/L. AN ADDITIONAL RESULT OF 4 MMOL/L WAS ALSO PROVIDED. THE SAMPLE WAS TESTED ON A DIFFERENT C503 INSTRUMENT AND THE SAME RESULTS WERE OBTAINED. THE SPECIFIC RESULTS WERE NOT PROVIDED. A SECOND SAMPLE WAS OBTAINED FROM THE PATIENT AND THE SAME RESULTS WERE OBTAINED. THE SPECIFIC RESULTS WERE NOT PROVIDED. THE SAMPLE WAS TESTED ON A RADIOMETER ABL800 FLEX BLOOD GAS INSTRUMENT WITH ELEVATED RESULTS. THE PCO2 RESULTS FROM THE BLOOD GAS INSTRUMENT FROM THE PLASMA SAMPLE WERE 20.0 MMHG AND 23.9 MMHG. THE PCO2 RESULTS FROM THE BLOOD GAS INSTRUMENT USING A WHOLE BLOOD SAMPLE WERE 20.4 MMHG AND 19.3 MMHG. ADDITIONAL SAMPLES WERE OBTAINED FROM THE PATIENT AND TESTED ON DIFFERENT C503 INSTRUMENTS. SEE ATTACHED DATA FOR THE RESULTS. A LIPOGRAM WAS PERFORMED AND THE RESULTS SUGGEST A HIGHER LEVEL OF CHYLOMYCRON IN THE SAMPLE. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE RESULTS. THE C503 INSTRUMENT SERIAL NUMBER WAS NOT PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040412 ↗