ABL800 FLEXRecalls & reported problems across all models

We found 2 models of ABL800 FLEX by Radiometer Medical ApS in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2017 and Sep 2, 2026 — classified as 7 injuries, 101 malfunctions.

The most frequently reported specific device problem is “High Readings” (33 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ABL800 FLEX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 31, 2024Open, Classified

   Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.

   Z-2426-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. May 18, 2022Open, Classified

   There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.

   Z-1321-2022 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported ABL800 FLEX problems

ABL800 FLEX models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ABL800 FLEX 393-800

  ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
  2 recalls81 reports
• ABL800 FLEX 393-801

  ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
  1 recall27 reports

Recent ABL800 FLEX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Low Readings

  Patient problems: Insufficient Information

  MAUDE report 50558285 ↗
• MalfunctionAug 20, 2026Missing Test Results

  Patient problems: Insufficient Information

  MAUDE report 50339048 ↗
• MalfunctionJul 31, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096445 ↗
• MalfunctionApr 20, 2026Date/Time-Related Software Problem

  RADIOMETER REFERENCE NUMBER (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED, THAT ON (B)(6) 2026, DURING A ROUTINE VISIT, THE ABL800 FLEX ANALYSER (SERIAL NUMBER (B)(6)) WAS RESTART. UPON REBOOT, THE DATE HAS BEEN REVERTED BACK TO (B)(6) 2007. THE TIME DISCREPANCY WAS NOTICED AND CAUSED PATIENT RESULTS TRANSMISSION TO FAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924836 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT ON (B)(6) 2026, AT 19:20, A BLOOD GAS ANALYSIS ON THE BLOOD GAS ANALYZER ABL800 FLEX ANALYZER (SERIAL NUMBER (B)(6)) WAS COMPLETED FOR THE PEDIATRIC PATIENT. THE REPORTED RESULTS SHOWED POTASSIUM (K) OF 2.5 MMOL/L AND SODIUM (NA) OF 117 MMOL/L. THE PATIENT WAS IMMEDIATELY ASSESSED AND SHOWED NO SIGNS OF CARDIAC ARRHYTHMIA, SEIZURES, OR OTHER ABNORMAL MANIFESTATIONS. COMPARED WITH THE BLOOD GAS RESULTS AT 06:35 THE SAME MORNING (K 3.4 MMOL/L, NA 132 MMOL/L), THE VALUES DIFFERED SIGNIFICANTLY. AN URGENT REPEAT BIOCHEMICAL ELECTROLYTE TEST WAS ORDERED IMMEDIATELY. IN THE MEANTIME, LOW-DOSE HYPERTONIC SODIUM AND POTASSIUM CITRATE SUPPLEMENTATION WERE INITIATED. AT 20:39, THE BIOCHEMICAL ELECTROLYTE RESULTS WERE REPORTED AS K 3.9 MMOL/L AND NA 134 MMOL/L, AND HYPERTONIC SODIUM AND POTASSIUM CITRATE SUPPLEMENTATION WERE IMMEDIATELY DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907803 ↗
• MalfunctionApr 9, 2026Unable to Obtain Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER EXPERIENCED SPORADICALLY ABORTED MEASUREMENTS ON THE ABL800 FLEX (SERIAL NUMBER: (B)(6). RADIOMETER FIELD SERVICE ENGINEER HAD CHECKED THE DATA LOGS AND ACTIVITY LOGS OF THE ANALYZER AND COULD NOT FIND THE INFORMATION REGARDING THE ABORTED MEASUREMENTS. 10 TEST MEASUREMENTS WERE CONDUCTED WITHOUT ISSUE. SEVERAL MAINTENANCE AND SERVICE WERE CONDUCTED WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829483 ↗
• MalfunctionMar 31, 2026Low Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025 SEVERAL MEASUREMENTS HAD UNEXPLAINED DISCREPANCIES IN THE SODIUM VALUES ON THE ABL800 FLEX (SERIAL NUMBER: (B)(6)). TWO MEASUREMENTS WERE PROVIDED BY THE CUSTOMER: 143 MMOL/L AND 150 MMOL/L (DISCREPANT). A SECOND SET OF MEASUREMENTS WAS PROVIDED. THE MEASUREMENT TAKEN ON (B)(6) 2025 AT 4:24 P.M., WITH A VALUE OF 144 MMOL/L, SHOULD REPRESENT THE ACTUAL VALUE COMPARED TO THE MEASUREMENT TAKEN ON (B)(6) 2025 AT 8:42 P.M. WITH NA = 155 MMOL/L (DISCREPANT).

  Patient problems: Insufficient Information

  MAUDE report 24740711 ↗
• MalfunctionMar 18, 2026High Readings

  RADIOMETER REFERENCE NUMBER (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED DIFFERENT RESULTS IN MEASURING CHLORIDES BETWEEN ABL800 FLEX ANALYZER (SERIAL NUMBER (B)(6)) AND BECKMAN COULTER AU. THE COMPARISON RESULTS PROVIDED INCLUDE 4 DIFFERENT SAMPLES AND ARE CONSIDERABLY HIGHER FOR ABL800 FLEX ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626132 ↗
• MalfunctionFeb 19, 2026High Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED THAT THEIR ABL800 FLEX ANALYZER (SERIAL NUMBER; (B)(6)) MEASURED APPROXIMATELY 20 MMOL TOO HIGH FOR SODIUM (NA) FOR ABOUT AN HOUR FROM 11:51 TO 12:53 ON (B)(6) 2026. A SAMPLE WAS RUN ON THE ANALYZER AT 11:48, BUT IT DID NOT PRODUCE A RESULT, AND OTHER SAMPLES FROM THE SAME TIME ON DIFFERENT ANALYSIS EQUIPMENT ALSO FAILED, AS THEY WERE COAGULATED. AT 12:53, THE ANALYZER RESOLVED THE PROBLEM ON ITS OWN AND MEASURED CORRECTLY AGAIN. THE PATIENT HAS NA RESULTS OF 132 MMOL/L ON THE 16/2-26 AT 10:31 FROM ALINITY INSTRUMENT. ON THE ABL800 FLEX ANALYZER THEY RECEIVED NA RESULTS ON 157 MMOL/L 16/2-26 AT 12:00 AND 153 MMOL/L 16/2-26 AT 12:27 THEY HAVE CHECKED IF THERE WAS SALINE WATER RUNNING BUT THAT WAS APPARENTLY NOT THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387691 ↗
• MalfunctionFeb 16, 2026Low Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025 SEVERAL MEASUREMENTS HAD UNEXPLAINED DISCREPANCIES IN THE SODIUM VALUES ON THE ABL800 FLEX (SERIAL NUMBER: (B)(6). TWO MEASUREMENTS WERE PROVIDED BY THE CUSTOMER: 143 MMOL/L AND 150 MMOL/L (DISCREPANT). A SECOND SET OF MEASUREMENTS WAS PROVIDED. THE MEASUREMENT TAKEN ON (B)(6) 2025 AT 4:24 P.M., WITH A VALUE OF 144 MMOL/L, SHOULD REPRESENT THE ACTUAL VALUE COMPARED TO THE MEASUREMENT TAKEN ON (B)(6) 2025 AT 8:42 P.M. WITH NA = 155 MMOL/L (DISCREPANT).

  Patient problems: Insufficient Information

  MAUDE report 24342774 ↗
• MalfunctionFeb 4, 2026Low Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT ON (B)(6) 2026, THE RADIOMETER BLOOD GAS ANALYZER ABL800 FLEX (SERIAL NUMBER (B)(6)) MEASURED FALSELY LOW LACTATE (CLAC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256062 ↗
• MalfunctionNov 19, 2025Low Readings; Low Readings

  RADIOMETER REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, FIVE PATIENT SAMPLES MEASURED ON THE ABL800 FLEX ANALYZER (SERIAL NO. (B)(6) WERE RECALLED ON 2025-03-18. AT 13:36, THE ANALYZER WAS PLACED IN STOP MODE WITHOUT ANY DOCUMENTED ACTION, REPLACEMENT, OR INDICATION OF THE REASON. -CALIBRATION WAS CONFIRMED AS OK AT 11:34. -CREATININE RESULTS WERE ACCEPTABLE AT 13:22 BUT NOT AT 14:00, WHEN THE FIRST PATIENT SAMPLE SHOWED AN ABNORMALLY LOW CREATININE VALUE. -AT 14:04, ANOTHER SAMPLE WAS ANALYZED, RETURNING "?" FOR ALL PARAMETERS. NO INSTRUMENT ALARM WAS TRIGGERED AFTER THIS EVENT. -AT 14:31, THE EQUALIS CONTROL WAS ANALYZED, YIELDING A RESULT OF 45 MOL/L COMPARED TO THE METHOD GROUP RESULT OF 128 MOL/L. THE DEVIATION WAS SO SIGNIFICANT THAT THE VALUE WAS EXCLUDED FROM STATISTICAL ANALYSIS. THERE WAS NO HARM TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593118 ↗
• MalfunctionNov 4, 2025Computer Software Problem; Computer Software Problem

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER COMPLAINS ABOUT ABL800 FLEX ANALYZER (SERIAL NO. (B)(6) BRIEFLY SHOWED THE BASIC INPUT/OUTPUT SYSTEM (BIOS) INFO AND THEN GAVE BLACK SCREEN DESPITE REPLACEMENT OF CENTRAL PROCESSING UNIT (CPU) UNIT. NO ADVERSE EVENT OR SERIOUS INJURY WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462308 ↗
• MalfunctionOct 22, 2025Computer Software Problem; Computer Software Problem

  RADIOMETER COMPLAINT REFERENCE (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER COMPLAINS ABOUT A WHITE SCREEN DURING SAMPLE MEASUREMENT BY USING ABL800 (SERIAL NUMBER (B)(6) FLEXQ MODULE AND ABORTION OF SAMPLE. AN OPERATOR PLACED A SAMPLE INTO FLEXQ MODULE AND LOGGED OFF. DURING SAMPLE MEASUREMENT OF ABOVE-MENTIONED SAMPLE ANOTHER OPERATOR PUT A FURTHER SAMPLE INTO FLEXQ MODULE FOLLOWED BY ENTRY OF PATIENT DATA. AFTER ENTRY OF PATIENT DATA, THE ANALYZER SCREEN TURNS WHITE, BUT ANALYZER UNIT (AU) CONTINUED WORKING. AFTER COMPLETION OF AU ACTIVITIES, THE OPERATOR RESTARTED THE ANALYZER. THE RUNNING MEASUREMENT WAS ABORTED BUT THE ANALYZER WORKED WITHOUT PROBLEMS AND AS INTENDED AFTER RESTART. NO ADVERSE EVENT OR SERIOUS INJURY WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356881 ↗
• MalfunctionOct 15, 2025Incorrect Measurement; Incorrect Measurement

  RADIOMETER COMPLAINT REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, THE ABL800 FLEX ANALYZER REPORTED FALSELY HIGH SODIUM (NA) VALUES AND FALSELY LOW CHLORIDE (CL) VALUES, LEADING TO INACCURATELY LOW ANION GAP READINGS. THE RECORDED ANION GAP VALUES RANGED FROM 0.2 TO 2.9 MMOL/L, WHEREAS THE EXPECTED RANGE WAS 10 TO 16 MMOL/L. THIS ISSUE OCCURRED BETWEEN (B)(6) 2025. IT WAS REPORTED TO HAVE RESULTED IN INAPPROPRIATE TREATMENT, BUT NO ADVERSE EVENTS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288150 ↗

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