ABL80 FLEX CO-OX Analyzer 393-841Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05700693938417), received between Jan 3, 2018 and Feb 13, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Readings” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023Low Readings; Low Readings

  THIS IS A DATA COMPLAINT ABOUT PCO2. ON (B)(6) 2022, THE CUSTOMER MEASURED PATIENT BLOOD ON ABL80 CO-OX (PART NUMBER: 393-841, SERIAL NUMBER: (B)(4)) WITH SENSOR CASSETTE (PART NUMBER: 945-719, LOT NUMBER: 343659) IN THE ER. THE PCO2 RESULT WAS 41.8 MMHG. HOWEVER, AFTER THAT THE PATIENT TRANSPORT TO HCU, THEY MEASURED THE PATIENT BLOOD AGAIN ON ABL825 FLEX (SERIAL NUMBER: (B)(4)) IN THE HCU ON (B)(6) 2022; THE PCO2 RESULT WAS 88.8 MMHG. THEN, THE DR. REPORTED THE FIRST PCO2 RESULT ON ABL80 AS FALSE LOW, BASED ON THE PATIENT CONDITION. THE MEASUREMENT OF 88.8 MMHG WAS THE EXPECTED VALUE FROM THE DOCTOR. AFTER RECEIVING THIS COMPLAINT FROM THE CUSTOMER, THE FIELD REP VISITED THE HOSPITAL AND CHECKED THE ABL80 CO-OX. HE MEASURED MQC ON THE ABL80 CO-OX AND THE RESULT WAS FAILED. AFTERWARDS, HE REPLACED THE SENSOR CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363976 ↗
• MalfunctionFeb 18, 2022High Readings; Low Readings; High Readings; Low Readings

  CUSTOMER CALLED IN OVER THE WEEKEND STATING THAT A PATIENT WAS TREATED BASED ON THE RESULTS FROM THE ANALYZER. PATIENT HAD 3 SAMPLES RAN, ALL REPRESENTING METABOLIC ACIDOSIS WHICH THE PATIENT WAS TREATED ON. THE HCO3(P) WAS USED FOR TREATMENT BY GIVING PATIENT SODIUM BICARB BY ONE TIME IV DOSE AS WELL AS IV DRIP. PATIENT WAS TREATED ON FIRST AND SECOND SAMPLES, THEN THIRD SAMPLE WAS WHEN THE RESULTS WERE QUESTIONED BY THERAPIST. RAN 2 ADDITIONAL PATIENT SAMPLES, THEN TRANSPORTED SAMPLES TO SISTER HOSPITAL TO BE RAN AND BOTH SAMPLES THE PH AND HCO3(P) WERE DIFFERENT FROM THIS ANALYZER. CUSTOMER ALSO RAN A NURSE'S SAMPLE WHICH WAS OFF FROM NORMAL VALUES. ONLY ONE PATIENT WAS TREATED BASED ON BLOOD GAS RESULTS. PATIENT DID NOT HAVE ANY ADVERSE EFFECTS BASED ON ERRONEOUS TREATMENT NOR ANY NEGATIVE REACTIONS. ON (B)(6) 2022 @ 06:05:23 PATIENT RESULT SAMPLE #(B)(6) WAS RAN. BASED ON THE RESULTS OF HCO3(P) AND PH, PATIENT WAS GIVEN SODIUM BICARBONATE TO RAISE HCO3(P). ON (B)(6) 2022 08:44:08 PATIENT RESULT SAMPLE #(B)(6) WAS RAN TO RECHECK PATIENTS HCO3(P) AND PH, STILL LOW AND ADDITIONAL SODIUM BICARBONATE WAS GIVEN TO PATIENT. ON (B)(6) 2022 @ 13:36:52 PATIENT RESULT SAMPLE #(B)(6) WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564029 ↗
• MalfunctionSep 29, 2021High Readings; High Readings

  MS. (B)(6) REPORTED A DEVIATION OF POTASSIUM DURING THE BLOOD MEASUREMENT OF A PATIENT. ANOTHER SAMPLE WAS TAKEN FROM THE PATIENT AND MEASURED ON THE ABL90 ANALYZER IN THE EMERGENCY ROOM. IN THIS MEASUREMENT, THE VALUE WAS PLAUSIBLE. THE RESULTS OF THE MEASUREMENTS FROM THE ABL80 FLEX CO-OX ANALYZER WAS: 2814 ((B)(6) 2021 / 08:55 A.M.): K OF 9.95 MMOL / L -> RESULT DOES NOT CORRESPOND TO THE PATIENT'S CONDITION 2815 ((B)(6) 2021 / 08:57 A.M.): K OF 8.47 MMOL / L -> RESULT DOES NOT CORRESPOND TO THE PATIENT'S CONDITION THE COMPARATIVE RESULTS OF THE MEASUREMENT FROM THE ABL90 ANALYZER IN THE ER WAS: (B)(6) 2021 (10:35 A.M.): K OF 4.3 MMOL / L -> MEASURED VALUE PLAUSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551015 ↗
• MalfunctionDec 23, 2020High Readings; High Readings

  ACCORDING TO THE COMPLAINT, CUSTOMER COMPLAINS ABOUT ABL80 CO-OX WITH SERIAL NUMBER: (B)(6) DEVIATION ON PARAMETER K ABOUT CA. 2MMOL/L TOO HIGH COMPARED TO OTHER ABL80. ABL80 COOX. SN: (B)(6). K: 4.31 MMOL/L. ABL80 COOX . SN: (B)(6). K: 4.32 MMOL/L. ABL80 COOX . SN: (B)(6). K: 6.23 MMOL/L. DISCREPANCY: 6.23-4.31=1.92 MMOL/L (FALSE HIGH). THERE ARE NO REPORTS OF DEATH, SERIOUS INJURY OR MALTREATMENT. ALSO, NO INFORMATION REGARDING GENDER, AGE, ETHNICITY OR RACE OF THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11067566 ↗
• MalfunctionJan 3, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A BLOOD GAS SAMPLE TESTED FROM A PATIENT WAS LOW ON THE BICARB. HE WAS THEN TAKEN TO THE ER AND GIVEN BICARB AS TREATMENT. THE PATIENT WAS RELEASED AND SENT HOME WITH MORE BICARB TO TAKE. WHEN THE OPERATOR SAW THE BLOOD GAS RESULTS OF THE PATIENT RUN ON ANOTHER ANALYZER, A DIFFERENCE IN VALUES WAS SEEN. THE THERAPISTS WENT TO THE ER TO CHECK ON THAT PATIENT TO FIND OUT THAT THE PATIENT HAD ALREADY BEEN RELEASED. THEY REQUESTED THE PATIENT TO RETURN FOR A REPEAT BLOOD GAS AND MARKED THE ANALYZER TO NOT BE USED UNTIL IT CAN BE CHECKED/REPAIRED BY A FIELD SERVICE ENGINEER. A FIELD SERVICE VISITED THE SITE TO EVALUATE THE ANALYZER. THE ENGINEER REVIEWED THE ANALYZER LOGS AND OBSERVED THE PH AND PCO2 PARAMETERS HAD FAILED EXTERNAL QUALITY CHECKS (QC). RESULTS FROM THESE PARAMETERS ARE USED IN THE DERIVATION OF BICARB. FURTHER REVIEW DETERMINED THAT THE QC LOCKOUT FEATURE WAS NOT ACTIVE ON THIS ANALYZER. THE QC LOCKOUT FEATURE WOULD HAVE DISABLED ANALYSIS ON THE PH AND PCO2 PARAMETERS IN THE EVENT OF A QC FAILURE. THE SERVICE ENGINEER ALSO OBSERVED CORROSION ON THE SENSOR CONNECTOR BOARD. CORRECTIVE ACTION: REPLACED SENSOR CONNECTOR BOARD DUE TO OBSERVED CORROSION. THE ENGINEER ACTIVATED

  Patient problems: Abnormal Blood Gases

  MAUDE report 7159512 ↗