ABL90 FLEX PLUS Analyzer 393-092Recalls & reported problems

Summary

The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 05700693930923), received between Aug 24, 2018 and May 20, 2026 — classified as 1 death, 5 injuries, 169 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (61 reports).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

1. Mar 21, 2025Open, Classified

   ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

   Z-1659-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 175 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Computer Software Problem

  ACCORDING TO THE COMPLAINT (RADIOMETER REFERENCE NUMBER: (B)(4), THE CUSTOMER REPORTED THAT DURING TWO SAMPLE MEASUREMENTS USING THE ABL90 FLEX PLUS (SERIAL NUMBER: (B)(6) APPROXIMATELY 2 HOURS APART, THE PATIENT IDS WERE SCANNED BUT THE ANALYZER DID NOT ACCEPT THE BARCODE. NO REPORT OF SERIOUS INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228373 ↗
• MalfunctionMay 13, 2026Low Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO COMPLAINT, CUSTOMER REPORTED THAT THERE HAVE BEEN 5 DIFFERENT PATIENT SAMPLES THAT HAVE HAD VERY LOW TOTAL HEMOGLOBIN (THB) RESULTS RANGING FROM 0.1 TO 12 G/L BETWEEN (B)(6) 2026 FROM BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)). THERE WERE NO ERROR MESSAGES ON THE SAMPLES AND SAMPLES FROM THESE PATIENTS PERFORMED IN THE LAB HAVE GIVEN NORMAL RESULTS. THE SAMPLE MEASUREMENTS ARE AS FOLLOWS: SAMPLE ID: MEASUREMENT TIME AND DATE: PARAMETER: RESULT: (B)(6) 22:09 (B)(6) 2026 THB, 1.4 G/L DISCREPANT, LAB RESULT 05:30 (B)(6) 2026 THB, 96 G/L COMPARISON, LAB RESULT 22:16 (B)(6) 2026 THB, 96 G/L COMPARISON, (B)(6) 22:11 (B)(6) 2026 THB, 70 G/L COMPARISON; (B)(6) 14:44 (B)(6) 2026 THB, 0.3 G/L DISCREPANT, LAB RESULT 07:40 (B)(6) 2026 THB, 86 G/L COMPARISON, LAB RESULT 07:38 (B)(6) 2026 THB, 90 G/L COMPARISON, (B)(6) 13:46 (B)(6) 2026 THB, 85 G/L COMPARISON, (B)(6) 09:34 (B)(6) 2026 THB, 84 G/L COMPARISON; (B)(6) 11:08 (B)(6) 2026 THB, 0.1 G/L DISCREPANT, LAB RESULT 09:09 (B)(6) 2026 THB, 108 G/L COMPARISON, LAB RESULT 14:31 (B)(6) 2026 THB, 102 G/L COMPARISON, (B)(6) 17:55 (B)(6) 2026 THB, 107 G/L COMPARISON, (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158520 ↗
• MalfunctionMay 11, 2026Low Readings

  RADIOMETER REFERENCE (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED DISCREPANCIES IN HAEMOGLOBIN (THB) AND POTASSIUM (K+) RESULTS ON THE BLOOD GAS ANALYZER ABL90 FLEX PLUS (SERIAL NUMBER (B)(6)) WHEN THE SAME PATIENT BLOOD (DIFFERENT SPECIMEN BUT TAKEN AT THE SAME TIME) WAS ANALYZED ON THE LABORATORY ANALYZER. THE ANALYZER USED FOR THE COMPARISON MEASUREMENTS WAS THE SYSMEX XN SERIES FOR HAEMOGLOBIN (HB) AND ABBOTT ALINITY FOR POTASSIUM (K+). BOTH THB AND K+ ON ABL90 REPORTED A LOWER READING AS COMPARED TO THE LABORATORY ANALYZERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135300 ↗
• MalfunctionMay 7, 2026High Readings; Low Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT ON (B)(6) 2026, THE RADIOMETER BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (B)(6) GAVE SODIUM (NA) EXTREME HIGH AND PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) EXTREME LOW RESULTS AT SAMPLES WITH HIGH HEMATOCRIT (HCT). DISCREPANT VALUES PROVIDED ARE COMPARED VS. COMPARISON MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111408 ↗
• MalfunctionMay 7, 2026High Readings

  RADIOMETER REFERENCE NUMBER (B)(4). ACCORDING TO COMPLAINT, CUSTOMER REPORTED POTASSIUM RESULTS ON THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)) IS ELEVATED AND BELIEVED TO BE INCORRECT. WHEN COMPARED TO ANOTHER DEVICE / LAB ANALYZER, THE RESULTS WERE LOWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25109409 ↗
• MalfunctionApr 23, 2026High Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2026, 13:00 A VENOUS BLOOD SAMPLE WAS MEASURED ON THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6)) AND A POTASSIUM RESULT OF 6.1MMOL/L WAS OBTAINED. A PLASMA SAMPLE WAS MEASURED ON A DIFFERENT INSTRUMENT ON (B)(6) 2026, 13:24 AND A POTASSIUM RESULT OF 3.8MMOL/L WAS OBTAINED. BOTH BLOOD GAS AND HEPARIN SAMPLE WERE COLLECTED AT THE SAME TIME AND THERE WAS NO HAEMOLYSIS COMMENT ATTACHED TO THE GENERAL CHEMISTRY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965168 ↗
• MalfunctionApr 16, 2026Incorrect Measurement

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6)) DISPLAYED ERROR MESSAGES 0521: INHOMOGENOUS SAMPLE ERROR (CAUSES 1387: GLU NOT USABLE) AND 1070: CL- RESPONSE ERROR. HOWEVER OTHER PARAMETERS RESULT REPORTED WITHOUT ERROR MESSAGE SOME INCLUDING PH, HCO3 APPEAR TO BE DISCREPANT. THE FOLLOWING PH MEASUREMENTS WERE OBTAINED: 7.340 AND 7.601. PCO2 MEASUREMENTS OF 38.0MMHG AND 47.2MMHG WERE OBTAINED TOO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896077 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak; Infusion or Flow Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT ON (B)(6) 2026 A TECHNICIAN HAD A PATIENT SAMPLE RUNNING ON THE RADIOMETER BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6). BLOOD CAME BACK ON HER AND GOT BLOOD ON HER BADGE AND IN THE FACE, AND SHE USED AN EYE WASH STATION FOR PRECAUTIONARY MEASURES. SHE DID NOT GO TO THE DOCTOR BUT DID FILL OUT AN EMPLOYER EVENT REPORT DUE TO EXPOSER. ERRORS AT THE TIME WERE FAILURE TO ASPIRATE. THE ABL90 FLEX PLUS ANALYZER IS OPERATING NORMALLY AT THIS TIME.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24856117 ↗
• MalfunctionApr 13, 2026Low Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(4) A SAMPLE WAS MEASURED ON THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6) AND THE FOLLOWING HEMOGLOBIN (CTHB) RESULTS WERE OBTAINED: 1) (B)(6) 2026, 19:10: 60G/L 2) (B)(6) 2026, 18:39: 105G/L (COMPARISON RESULT FROM THE LAB) ANOTHER SAMPLE WAS ALSO MEASURED ON(B)(6) 2026: 3) (B)(6) 2026, 14:42: 31G/L 4) (B)(6) 2026, 15:06: 138G/L (COMPARISON RESULT FROM ANOTHER ABL90 FLEX PLUS ANALYZER) 5) (B)(6) 2026, 15:13: 137G/L (COMPARISON RESULT) BASED ON THESE, THE CUSTOMER HAD REPORTED THE 60G/L AND 31G/L CTHB MEASUREMENTS FROM THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6) AS FALSE LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24856082 ↗
• MalfunctionApr 7, 2026Low Readings

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, SAMPLES WERE MEASURED ON THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6) WITH THE FOLLOWING RESULTS ON THE CALCIUM PARAMETER: 1) ON (B)(6) 2026, 12:23: 0.85 MMOL/L (DISCREPANT) - MEASUREMENT WAS MARKED WITH (?) AND QC NOT APPROVED. 2) ON (B)(6) 2026, 13:11: 0.94 MMOL/L (DISCREPANT), 3) ON (B)(6) 2026, 13:12: 1.2 MMOL/L (DISCREPANT), 4) (B)(6) 2026, 13:51: 0.6 MMOL/L (DISCREPANT), 5) (B)(6) 2026, 15:06: 0.86 MMOL/L (DISCREPANT), 6) (B)(6) 2026, 15:12: 1.24 MMOL/L (COMPARISON), THE PATIENT RECEIVED CALCIUM INTRAVENOUSLY.

  Patient problems: Insufficient Information

  MAUDE report 24799479 ↗
• MalfunctionMar 31, 2026Computer Software Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED SPORADICALLY ISSUES WITH THE BARCODE SCANNER, WHERE DIGITS WERE CUT OFF. THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6) SPORADICALLY READS ONLY THE FIRST TWO DIGITS OF THE BARCODE AND CUTS OFF THE REMAINING DIGITS. NEW INFORMATION RECEIVED 17MAR2026: THE PATIENT'S NAME IS SCANNED TO IDENTIFY THE BLOOD GAS ANALYSIS, BUT A DIFFERENT NAME APPEARS ON THE PRINTOUT. THE NUMBER 11 APPEARS IN THE PATIENT ID FIELD! THIS OCCURS REPEATEDLY IN IRREGULAR AND RARE MEASUREMENTS. THE CLINIC AND, SUBSEQUENTLY, THE MANUFACTURER'S TECHNICIAN CARRY OUT UNSUCCESSFUL TROUBLESHOOTING, BUT THE TECHNICIAN LEARNS FROM ONE OF HIS COLLEAGUES THAT HE IS AWARE OF OTHER RARE, SIMILAR CASES. ALL OF THEM HAVE THE PATIENT ID (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739635 ↗
• MalfunctionMar 26, 2026High Readings

  COMPLAINT REFERENCE (B)(4) ACCORDING TO THE COMPLAINT, ON MARCH 7TH, THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6) REPORTED A FALSE HIGH RESULT FOR CTHB OF 139 G/L. THE SAMPLE WAS MEASURED ON A SYSMEX ANALYZER WITH A RESULT OF 72 G/L. A NEW COLLECTION WAS RERUN ON AN ABL800 AND MEASURED 101G/L. ALL QC AND CALIBRATIONS WERE IN RANGE AND THERE WAS NO ISSUE WITH ANY INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698813 ↗
• MalfunctionMar 23, 2026Computer Software Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED THAT WHEN THE OPERATOR PRESSES THE SYRINGE BUTTON TO START A GAS ANALYSIS BEFORE SCANNING THE BARCODE, THE ABL90 FLEX ANALYZER (SERIAL NUMBER (B)(6)) MAY REBOOT WITHOUT WARNING. THE REBOOT MAY ALSO OCCUR DURING CONFIGURATION CHANGES IN THE INSTRUMENT MENU. THE BEHAVIOR IS RANDOM AND DISRUPTS ROUTINE OPERATION. AFTER THE REBOOT, ONE OF THE FOLLOWING OCCURS: THE INSTRUMENT ENTERS A 5 MINUTE WARM START, OR IT DIRECTLY RAISES A FLUIDICS ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661802 ↗
• MalfunctionMar 23, 2026Computer Software Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED THAT WHEN THE OPERATOR PRESSES THE SYRINGE BUTTON TO START A GAS ANALYSIS [?] BEFORE SCANNING THE BARCODE, THE ABL90 FLEX ANALYZER (SERIAL NUMBER (B)(6) MAY REBOOT WITHOUT WARNING. THE REBOOT MAY ALSO OCCUR DURING CONFIGURATION CHANGES IN THE INSTRUMENT MENU. THE BEHAVIOR IS RANDOM AND DISRUPTS ROUTINE OPERATION. AFTER THE REBOOT, ONE OF THE FOLLOWING OCCURS: - THE INSTRUMENT ENTERS A 5 MINUTE WARM START, OR - IT DIRECTLY RAISES A FLUIDICS ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660788 ↗
• MalfunctionMar 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, A RENTED BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)) WAS USED BY THE CUSTOMER AS A TEMPORARY ALTERNATIVE, AS THEIR USUAL ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)) NEEDED REPAIR. THE FIELD SERVICE ENGINEER (FSE) SET UP THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)) UNDER THE HOSPITAL'S USAGE CONDITIONS AND CONDUCTED AN ONLINE TEST IN DEMO MODE. HOWEVER, THE FSE FORGOT TO TURN OFF THE DEMO MODE. AFTER THAT, THE CUSTOMER MEASURED PATIENT SAMPLES ON THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)) WITHOUT NOTICING IN DEMO MODE, BUT THEY QUICKLY REALIZED IT. AS A RESULT, NO HEALTH PROBLEMS WERE REPORTED IN THIS CASE. THIS IS CLEARLY HUMAN ERROR REPORT, AND RADIOMETER JAPAN (RKK) WILL ONCE AGAIN ISSUE A WARNING TO ALL EMPLOYEES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649267 ↗
• MalfunctionMar 12, 2026Imprecise or Erratic Results

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT ON (B)(6) 2026 AND (B)(6) 2026, THE BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)) GAVE ERRATIC PCO2 RESULTS, ALSO WHEN COMPARED TO ANOTHER ANALYZER ((B)(6)) IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS ON A NON-INVASIVE VENTILATOR FOR WHICH THEY DID NOT CHANGE THE SETTINGS OVER THE COURSE OF THE READINGS THEY ARE CONCERNED ABOUT. THEY WOULD HAVE EXPECTED THE PCO2 TO COME DOWN OVER THE TWO DAYS THEY HAVE READINGS FOR, BUT THEY HAD TWO ERRATIC READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579775 ↗
• MalfunctionMar 12, 2026Computer Software Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT WHEN THE PATIENT ORDER IS SCANNED AND ASPIRATED THE SAMPLE WITH THE BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)), THE PROGRAM SHOWS AN UNEXPECTED ERROR WITH A BLUE SCREEN THAT CAUSES REBOOTING OF THE ANALYZER. THE SERVICE DUMP LOGS THREE CRASHES: (B)(6) 2026 13:59:47, (B)(6) 2026, 23:10:58 AND (B)(6) 2026, 23:52:02. THE CRASHES FROM THE 26TH ARE BOTH LOST SAMPLES. THE CRASH FROM THE 25TH IS NOT. MOST CERTAINLY OPERATOR WAS EDITING AN EXISTING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577812 ↗
• MalfunctionMar 12, 2026Computer Software Problem

  RADIOMETER REFERENCE NUMBER: (B)(4) ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT WHEN THE PATIENT ORDER IS SCANNED AND ASPIRATED THE SAMPLE WITH THE BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6), THE PROGRAM SHOWS AN UNEXPECTED ERROR WITH A BLUE SCREEN THAT CAUSES REBOOTING OF THE ANALYZER. THE SERVICE DUMP LOGS TWO CRASHES: (B)(6) 2026 23:11:58 AND (B)(6) 2026 23:48:29. THE SAMPLE WAS LOST IN BOTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577766 ↗
• MalfunctionMar 9, 2026High Readings

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT ON (B)(6) 2026, THE BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6) GAVE A FALSE HIGH POTASSIUM (K) RESULT, COMPARED TO THE SAMPLE RUN IN THE EMERGENCY DEPARTMENT (ED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543266 ↗
• MalfunctionMar 6, 2026Computer Software Problem

  RADIOMETER COMPLAINT REFERENCE (B)(4) ACCORDING TO THE COMPLIANT, WHEN CUSTOMER RUNS A SAMPLE MEASUREMENT, THE ABL90 FLEX ANALYZER DISPLAYS A MESSAGE THAT THE ANALYZER HAS ENCOUNTERED AN UNEXPECTED ERROR AND THE ANALYZER RESTARTS. INVESTIGATION OF THE DATA LOGS SHOW A CRASH ON FEBRUARY 22ND RESULTING IN A LOST SAMPLE AND ANOTHER CRASH ON FEBRUARY 23RD NOT RESULTING IN A LOST SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530350 ↗
• MalfunctionMar 6, 2026Computer Software Problem

  ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT WHEN THEY WILL RUN A SAMPLE ON THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6), AFTER SAMPLE MEASUREMENT A SCREEN POPS UP AND SAYS THERE WAS AN APPLICATION ERROR, AND DO THEY WANT TO RESTART THE ANALYZER YES OR NO. ANALYZER WILL SOMETIMES JUST REBOOT ON ITS OWN WITH NO POP UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528737 ↗
• MalfunctionMar 5, 2026Computer Software Problem

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, AFTER CONDUCTING A SAMPLE MEASUREMENT, THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6) PROMPTED AN APPLICATION ERROR AND ASKED IF THE USER WOULD LIKE TO CONDUCT A REBOOT. THE ANALYZER ON SOME OCCASIONS JUST REBOOTED AUTOMATICALLY WITH NO PROMPTS. WHEN A SAMPLE IS MEASURED, ANYWHERE FROM 1 TO 10 MINUTES LATER, THE ERROR WILL OCCUR INTERMITTENTLY. THE ANALYZER MAY DISPLAY AN ERROR MESSAGE, OR IT WILL JUST RESTART ON ITS OWN. THE DATA LOGS SHOWED TWO CRASHES. ONE ON 18FEB2026 AND ONE ON 21FEB2026. IN THE CRASH 21FEB2026 THE PATIENT SAMPLE IS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518068 ↗
• MalfunctionMar 5, 2026Computer Software Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED THAT AFTER THEY UPGRADED THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6)) TO SOFTWARE VERSION 3.6 ANALYZER GIVES A ROMA ERROR ASKING TO RESTART THE ANALYZER AFTER A PATIENT SAMPLE IS RUN. THE ANALYZER WILL THEN RESTART LOSING THE PATIENT SAMPLE RESULTS. THE SERVICE DUMP LOGS 24 CRASHES BETWEEN (B)(6) 2026 AND (B)(6) 2026. THERE WAS NO PATIENT SAMPLES LOST IN THESE CRASHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517756 ↗
• MalfunctionMar 5, 2026Computer Software Problem

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO THE COMPLAINT, THE CUSTOMER EXPERIENCED THAT AFTER THEY UPGRADED THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6)) TO SOFTWARE VERSION 3.6, ANALYZER GIVES A ROMA ERROR ASKING TO RESTART THE ANALYZER AFTER A PATIENT SAMPLE IS RUN. THE ANALYZER WILL THEN RESTART LOSING THE PATIENT SAMPLE RESULTS. THE SERVICE DUMP LOGS 14 CRASHES BETWEEN 19-FEB-2026 AND 25-FEB-2026. IN ONE OF THE CRASHES, ON (B)(6) 2026, THE PATIENT SAMPLE WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517524 ↗
• MalfunctionMar 3, 2026Mechanical Problem

  RADIOMETER COMPLAINT REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)) LOCATED IN THE NICU WARD HAS REPORTED REPEATED 1190 INLET OPEN ERRORS. WHEN THIS ERROR OCCURS, THE SAMPLE IS ABORTED, AND THE ANALYZER ENTERS AN "INTERVENTION REQUIRED" STATE WITH THE INSTRUCTION TO REPLACE THE INLET GASKET HOLDER. THE CUSTOMER FOLLOWED THE RECOMMENDED TROUBLESHOOTING STEPS WITHOUT REPLACING ANY COMPONENTS, AFTER WHICH THE ANALYZER RESUMED NORMAL OPERATION. NO DEATHS OR SERIOUS INJURIES HAVE BEEN REPORTED IN CONNECTION WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494817 ↗