ABL80 FLEX Analyzer 393-839Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05700693938394), received between Sep 27, 2018 and Oct 15, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Contamination” (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.

• InjuryOct 15, 2025High Test Results; High Test Results

  THE HOSPITAL REPORTED, ON (B)(6) 2025, AT 15:29, TWO BLOOD SAMPLES WERE SIMULTANEOUSLY DRAWN FROM THE PATIENT. ONE SAMPLE WAS USED FOR BLOOD GAS ANALYSIS ON ABL80 ANALYZER, WHILE THE OTHER WAS SENT TO THE LABORATORY FOR STAT RENAL FUNCTION TESTING. AT 15:49, THE ABL80 RESULT SHOWED A CRITICAL SODIUM VALUE OF 200 MMOL/L. UPON RECEIVING THE REPORT, THE PHYSICIAN IMMEDIATELY ASSESSED THE PATIENT, CONSIDERING POTENTIAL COMPLICATIONS SUCH AS ELECTROLYTE IMBALANCE, MULTIPLE ORGAN DYSFUNCTION, ACUTE KIDNEY INJURY, DEHYDRATION, ARRHYTHMIA, AND SUDDEN CARDIAC ARREST. IMMEDIATE ACTIONS INCLUDED UPGRADING THE PATIENT'S CARE LEVEL TO INTENSIVE, INITIATING CARDIAC MONITORING, DECLARING THE PATIENT'S CONDITION AS CRITICAL, AND ADMINISTERING DIURETICS AND FLUID REPLACEMENT TO LOWER SODIUM LEVELS, WHILE CLOSELY MONITORING THE PATIENT'S STATUS. AT 16:52, THE STAT RENAL FUNCTION TEST REPORT (FROM THE SAMPLE DRAWN AT THE SAME TIME AS THE BLOOD GAS ANALYSIS) SHOWED A SODIUM LEVEL OF 130 MMOL/L, INDICATING HYPONATREMIA. THE PHYSICIAN IMMEDIATELY DISCONTINUED THE DIURETICS AND INITIATED SODIUM SUPPLEMENTATION THERAPY. AT 22:43 THAT SAME DAY, A REPEAT STAT ELECTROLYTE TEST SHOWED A SODIUM LEVEL OF 132.0

  Patient problems: Hyponatremia

  MAUDE report 23290747 ↗
• InjurySep 27, 2018Contamination; Fracture; Contamination of Device Ingredient or Reagent; Contamination; Fracture; Contamination of Device Ingredient or Reagent

  A PATIENT ANALYSIS WAS PERFORMED ON THE SUBJECT ANALYZER, ABL80 FLEX SERIAL NUMBER (B)(4), AND BASED ON THE REPORTED HCT/THB RESULT THE PATIENT RECEIVED A BLOOD TRANSFUSION. THE USER WAS SUSPICIOUS OF THE SUBJECT ANALYZER'S RESULT AND THEREFORE PERFORMED ANOTHER MEASUREMENT ON A COMPARISON ABL80 FLEX THAT WAS ON-SITE. MEASURED RESULTS: SUBJECT ANALYZER: THB = 7.1G/DL HCT = 22%. COMPARISON ANALYZER: THB = 13.7 G/DL HCT = 42%. BASED ON A COMPARISON OF THE RESULTS BETWEEN THE SUBJECT AND COMPARISON ANALYZERS, THE USER CONCLUDED THAT THE SUBJECT ANALYZER RESULTS WERE INCORRECT AND THE BLOOD TRANSFUSION WAS UNNECESSARY. A SERVICE TECHNICIAN EVALUATED THE ANALYZER AND FOUND THAT THE ROLLER WHEEL ASSEMBLY WAS NOT WORKING PROPERLY. FURTHER INVESTIGATION REVEALED THE ROLLER WHEEL ASSEMBLY HOUSING WAS CRACKED AROUND A SET SCREW THAT IS USED TO SECURE THE ROLLER WHEEL ASSEMBLY TO THE ROLLER MOTOR SHAFT. THE CRACKED HOUSING RESULTED IN ROLLER WHEEL ASSEMBLY SLIPPAGE AFFECTING SAMPLE ASPIRATION AND FLUSHING. THE ISSUE WAS RESOLVED FOLLOWING REPLACEMENT OF THE ROLLER WHEEL ASSEMBLY.

  Patient problems: Abnormal Blood Gases

  MAUDE report 7914865 ↗