Ammonia II 07236450190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630936533), received between Jan 21, 2022 and Oct 20, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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.

• MalfunctionOct 20, 2025Low Test Results; Infusion or Flow Problem; Non Reproducible Results; Low Test Results; Infusion or Flow Problem; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 1 PATIENT SAMPLE TESTED WITH AMMONIA II ASSAY ON A COBAS 8000 C702 MODULE. INITIAL RESULT: 1361 UG/DL (TESTED WITH NORMAL MODE AND ACCOMPANIED BY A DATA FLAG). THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT WAS A VERY LOW NEGATIVE RESULT AND REPEATED THE SAMPLE USING DIFFERENT DILUTION FACTORS IN A DECREASE MODE: 1ST REPEAT RESULT: 1700 UG/DL (USING A DILUTION FACTOR 1:2). 2ND REPEAT RESULT: 300 UG/DL (USING A DILUTION FACTOR 1:50). THE SAMPLE WAS THEN REPEATED ON A DIFFERENT C702 MODULE IN ANOTHER SITE AND THE 4TH REPEAT RESULT WAS -600 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23339359 ↗
• MalfunctionDec 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NH3L AMMONIA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL NH3 RESULT WAS 135.1 UMOL/L. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE AS THERE ARE INTERNAL PROTOCOLS TO RERUN ALL SAMPLES THAT HAVE A NH3 RESULT OF >100 UMOL/L. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 338.6 UMOL/L AND 436.8 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347475 ↗
• MalfunctionAug 14, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NH3L AMMONIA RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE COMPARED TO CICALIQUID NH3 REAGENT. FOR SAMPLE 1, THE COBAS NH3L RESULT WAS 397 UG/DL. THE CIRCALIQUID RESULT WAS 150 UG/DL. FOR SAMPLE 2, THE COBAS NH3L RESULT WAS 341 UG/DL. THE CIRCALIQUID RESULT WAS 172 UG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541018 ↗
• InjuryOct 14, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR DIFFERENT SAMPLES FROM ONE PEDIATRIC PATIENT TESTED WITH THE NH3L2 (AMMONIA II) ASSAY ON A COBAS 8000 C 702 MODULE. THE PATIENT IS A PEDIATRIC PATIENT, BORN WITH CONGENITAL CITRULLINEMIA. THE PATIENT WAS APPROXIMATELY 2 MONTHS OLD AT THE TIME OF THIS EVENT AND HAS BEEN ADMITTED TO THE HOSPITAL FOR APPROXIMATELY HALF OF HER LIFE. THERE HAVE BEEN "A LOT" OF MEDICATION AND DIET CHANGES IMPLEMENTED DURING THESE MONTHS. ON (B)(6) 2022 AT 10:35 THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO AN ELEVATED S-AMMONIUM. THE CUSTOMER RECEIVED "REPEATEDLY" HIGH VALUES OF AMMONIA II WHICH "ONLY PARTIALLY" MATCH THE PATIENT'S CLINICAL CONDITION AND TREATMENT. REFER TO THE ATTACHED DATA ("PT-74668") FOR THE SPECIFIC RESULTS. ON (B)(6) 2022 THE RESULT FROM THE CUSTOMER'S C702 MODULE WAS 213.6 UMOL/L. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL WHERE THE AMMONIA II RESULT FROM A DIFFERENT SAMPLE OBTAINED APPROXIMATELY 7 HOURS LATER WAS APPROXIMATELY 50 UMOL/L ON A COBAS 8000 C 502 MODULE. AT HOME, THE PATIENT IS TREATED WITH A SPECIAL DIET INCLUDING ORAL SODIUM BENZOATE AND RAVICTI (GLYCEROL PHENYLBUTYRATE). THE HOME TREATMEN

  Patient problems: Insufficient Information

  MAUDE report 15607896 ↗
• MalfunctionJan 21, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE NH3L AMMONIA RESULTS FOR TWO PATIENTS WHOSE SAMPLES WERE TESTED ON A COBAS 8000 C702 MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER RERAN THE SAMPLES ON DECREASED MODE. THE SAMPLES WERE ALSO MANUALLY DILUTED. FOR PATIENT 1, THE REPORTER CALCULATED THE AVERAGE OF THE 1:2 AND 1:3 DILUTIONS AND REPORTED IT AS THE FINAL RESULT OF THE INITIAL SAMPLE. NEW SAMPLES WERE ALSO OBTAINED FROM THE PATIENT. ON (B)(6) 2021 AT 6:57, PATIENT 1 HAD AN INITIAL RESULT OF -200.2 UMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS -138.7 UMOL/L WITH A DATA FLAG. THE REPEAT RESULT AT 7:38 WAS -200.2 UMOL/L WITH A DATA FLAG. THE REPEAT RESULT AT 7:56 WAS 110.9 UMOL/L. THE DECREASED MODE RESULT WAS 180.1 UMOL/L. THE REPEAT RESULT AT 8:30 AT 1:5 DILUTION WAS 110 UMOL/L. THE REPEAT RESULT AT 8:31 AT 1:2 DILUTION WAS 126.4 UMOL/L. THE REPEAT RESULT AT 8:31 AT 1:3 DILUTION WAS 131.7 UMOL/L. THE REPEAT RESULT AT 8:32 AT 1:4 DILUTION WAS 120.4 UMOL/L. THE REPEAT RESULT AT 8:32 AT 1:10 DILUTION WAS 179 UMOL/L. THE REPEAT RESULT AT 9:53 USING AN UNDILUTED SAMPLE WAS -22.9 UMOL/L WITH A DATA FLAG. ON (B)(6) 2021,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13319614 ↗