Ammonia II 07229593190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630936526), received between Mar 2, 2023 and Jan 22, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Non Reproducible Results

  ROCHE DIAGNOSTICS RECEIVED A CUSTOMER COMPLAINT REGARDING ALLEGED LOW NH3L2 (AMMONIA) ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 6000 C501 MODULE. THE CUSTOMER STATED THEY LOADED A NEW REAGENT CASSETTE BEFORE THE HOLIDAYS BUT DID NOT PERFORM AN INITIAL CALIBRATION. THE CUSTOMER PERFORMED A CALIBRATION ON (B)(6) 2026, AND THE CALIBRATION PASSED. NO UNITS OF MEASURE WERE PROVIDED FOR THE AMMONIA ASSAY. THE PATIENT SAMPLE INITIALLY RECOVERED AN AMMONIA VALUE OF -76 WITH A DATA FLAG. THE TEST WAS RE-CALIBRATED AND THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 26.3 AND 26.8. THE LOW VALUES DID NOT AGREE WITH THE PATIENT'S CLINICAL HISTORY AND STATUS. THE PATIENT WAS TYPICALLY PATHOLOGICAL, WITH VALUES THAT WERE 120 TO 130. UPON FURTHER CALIBRATION AND REPETITION, THE SAMPLE RESULT WAS NEGATIVE AGAIN, ACCOMPANIED BY A DATA FLAG. NO SPECIFIC DATA WAS PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148769 ↗
• MalfunctionAug 14, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE AMMONIA II RESULTS FROM THE COBAS 6000 C 501 ANALYZER FOR A TOTAL OF SEVEN SAMPLES FROM THREE PATIENTS. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER. FIVE EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT WAS 318.6 UG/DL, AND THE REPEAT RESULTS WERE 28.3 UG/DL AND 28.5 UG/DL. SAMPLE 2 INITIAL RESULT WAS 332.6 UG/DL, AND THE REPEAT RESULT WAS 23.8 UG/DL. SAMPLE 3 INITIAL RESULT WAS 165.1 UG/DL, AND THE REPEAT RESULT WAS 75.8 UG/DL. SAMPLE 4 INITIAL RESULT WAS 212.3 UG/DL, AND THE REPEAT RESULT WAS 31.9 UG/DL. SAMPLE 5 INITIAL RESULT WAS 472.5 UG/DL. THE REPEAT RESULT WITH A 1:2 DILUTION WAS 486.0 UG/DL. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 44.6 UG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802463 ↗
• MalfunctionApr 4, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH AMMONIA II RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE DOCTOR QUESTIONED THE HIGH RESULT AS IT DID NOT MATCH THE CLINICAL PICTURE. THE INITIAL RESULT WAS 383 MOL/L. THE CUSTOMER REPEATED THE SAME AND THE RESULT WAS STILL HIGH. NO SPECIFIC DATA WAS PROVIDED. THE RESULT FROM A NEW SAMPLE FROM THE PATIENT TESTED AT ANOTHER LABORATORY WAS <10 MOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772756 ↗
• MalfunctionMar 17, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE AMMONIA II RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 34.2 UMOL/L. THE RESULT FROM AN ABBOTT ALINITY I ANALYZER WAS 302.4 UMOL/L. THE CUSTOMER REPEATED THE SAME SAMPLE ON BOTH ANALYZERS. THE REPEAT RESULT FROM THE COBAS C502 WAS 54.4 UMOL/L. THE REPEAT RESULT FROM THE ABBOTT ALINITY I WAS 309.8 UMOL/L. THE RESULTS FROM THE ABBOTT ALINITY I ANALYZER WERE BELIEVED TO BETTER FIT THE PATIENT'S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617667 ↗
• MalfunctionFeb 27, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NH3L AMMONIA RESULTS FOR 1 PATIENT EDTA PLASMA SAMPLE ON A COBAS 6000 C501 MODULE. THE INITIAL NH3L RESULT WAS 11.9 UMOL/L. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 42.9 UMOL/L WITH FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790747 ↗
• MalfunctionMar 2, 2023High Test Results; High Test Results

  THE INITIAL REPORTER ALLEGED THAT THEY RECEIVED HIGH RESULTS ON A RUN OF "ABOUT" 14 PATIENT SAMPLES TESTED WITH THE NH3L2 (AMMONIA II) ASSAY ON A COBAS 6000 C501 MODULE, SERIAL NUMBER (B)(4). IT WAS REPORTED THAT THE SAMPLES WERE REPEATED ON A SECOND COBAS C501 MODULE, SERIAL NUMBER (B)(4), RESULTING IN LOWER VALUES. OF THE DATA PROVIDED FIVE PATIENT SAMPLES RECEIVED DISCREPANT RESULTS TESTED WITH THE NH3L2 (AMMONIA II) ASSAY ON COBAS C501 MODULES: PATIENT SAMPLE #2: THE SAMPLE INITIALLY RESULTED IN AN NH3L2 VALUE OF 463 UG/DL. THE SAMPLE WAS REPEATED ON THE SECOND C501 MODULE, RESULTING IN A VALUE OF 30 UG/DL. A SAMPLE THAT WAS REDRAWN FROM THE PATIENT, RESULTED IN AN NH3L2 VALUE OF 28 UG/DL. PATIENT SAMPLE #4: THE SAMPLE INITIALLY RESULTED IN AN NH3L2 VALUE OF 457 UG/DL AND REPEATED AS 81 ON THE SECOND C501 MODULE. PATIENT SAMPLE #5: THE SAMPLE INITIALLY RESULTED IN AN NH3L2 VALUE OF 569 UG/DL AND REPEATED AS 243 UG/DL ON THE SECOND C501 MODULE. PATIENT SAMPLE #6: THE SAMPLE INITIALLY RESULTED IN AN NH3L2 VALUE OF 145 UG/DL AND REPEATED AS 20 UG/DL ON THE SECOND C501 MODULE. PATIENT SAMPLE #7: THE SAMPLE INITIALLY RESULTED IN AN NH3L2 VALUE OF 394 UG/DL AND REPATED AS 44 UG/DL ON

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypokalemia

  MAUDE report 16470997 ↗