Magnesium Gen.2 06407358190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630930821), received between Jun 28, 2022 and May 19, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 19, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE MAGNESIUM GEN.2 RESULTS FROM THE COBAS 8000 C702 MODULE. SAMPLE 1'S INITIAL RESULT WAS 0.8 MG/DL ACCOMPANIED BY A DATA FLAG, AND THE REPEAT RESULT WAS 1.7 MG/DL. SAMPLE 2'S INITIAL RESULT WAS 0.9 MG/DL ACCOMPANIED BY A DATA FLAG, AND THE REPEAT RESULT WAS 1.7 MG/DL. SAMPLE 3'S INITIAL RESULT WAS 0.8 MG/DL ACCOMPANIED BY A DATA FLAG, AND THE REPEAT RESULT WAS 2.1 MG/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. THE INITIAL RESULTS WERE QUESTIONED BECAUSE THEY WERE FLAGGED AS A CRITICAL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043383 ↗
• MalfunctionApr 28, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE MAGNESIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 2.67 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULTS WERE 2.11 MG/DL, 2.02 MG/DL, AND 2.07 MG/DL. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE CUSTOMER HAS HAD ONGOING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917475 ↗
• MalfunctionJul 15, 2024High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF QC ISSUES AND QUESTIONED HIGH RESULTS FOR 35 PATIENT SAMPLES TESTED FOR MAGNESIUM (MG2) ON A COBAS 8000 C 702 MODULE. THE CUSTOMER REMOVED THE ONBOARD REAGENT AND RECALIBRATED USING THE STANDBY REAGENT. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 3.6 MG/DL. THE REPEAT RESULT WAS 2.1 MG/DL. PATIENT 2 INITIAL RESULT WAS 3.4 MG/DL. THE REPEAT RESULT WAS 2.0 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19745564 ↗
• MalfunctionNov 7, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE MG2 MAGNESIUM GEN.2 RESULTS FROM FIVE PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. IT IS UNKNOWN IF THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER SUSPECTS IMPRECISION. THE REPORTER WAS ABLE TO PROVIDE THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: (B)(6). THE PATIENT SAMPLE WAS RUN ON LINE 2 OF THE MODULE. THE INITIAL RESULT WAS 0.68 MMOL/L. THE FIRST REPEAT RESULT WAS 0.47 MMOL/L. THE SECOND REPEAT RESULT WAS 0.42 MMOL/L. (B)(6). THE PATIENT SAMPLE WAS RUN ON LINE 2 OF THE MODULE. THE INITIAL RESULT WAS 1.15 MMOL/L. THE FIRST REPEAT RESULT WAS 0.79 MMOL/L. THE SECOND REPEAT RESULT WAS 0.81 MMOL/L. (B)(6). THE INITIAL RESULT FROM LINE 2 WAS 0.28 MMOL/L. THE FIRST REPEAT RESULT FROM LINE 2 WAS 0.55 MMOL/L. THE SECOND REPEAT RESULT FROM LINE 1 WAS 0.31 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085267 ↗
• MalfunctionJun 28, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE MG2 MAGNESIUM GEN.2 RESULTS FOR NINE PATIENTS TESTED ON A COBAS 8000 C 702 MODULE SERIAL NUMBER (B)(4). PRIOR TO PATIENT TESTING, THE CUSTOMER CONFIRMED CALIBRATION AND QC WERE WITHIN THE ACCEPTABLE RANGES. THE INITIAL MAGNESIUM RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED QC AND HAD RESULTS OUT OF THE ACCEPTABLE RANGES. THE CUSTOMER ATTEMPTED TO CALIBRATE THE REAGENT BUT HAD FAILING RESULTS. THE CUSTOMER REMOVED THE REAGENT PACK AND PERFORMED REPEAT TESTING WITH THE SAMPLES ON A DIFFERENT COBAS 8000 C 702 MODULE. PATIENT 1'S INITIAL MAGNESIUM RESULT WAS 0.8 MG/DL. THE PATIENT'S REPEAT MAGNESIUM RESULT WAS 2.0 MG/DL. PATIENT 2'S INITIAL MAGNESIUM RESULT WAS 0.7 MG/DL. THE PATIENT'S REPEAT MAGNESIUM RESULT WAS 1.8 MG/DL. PATIENT 3'S INITIAL MAGNESIUM RESULT WAS 0.8 MG/DL. THE PATIENT'S REPEAT MAGNESIUM RESULT WAS 2.1 MG/DL. PATIENT 4'S INITIAL MAGNESIUM RESULT WAS 1.2 MG/DL. THE PATIENT'S REPEAT MAGNESIUM RESULT WAS 3.2 MG/DL. PATIENT 5'S INITIAL MAGNESIUM RESULT WAS 0.8 MG/DL. THE PATIENT'S REPEAT MAGNESIUM RESULT WAS 2.0 MG/DL. PATIENT 6'S INITIAL MAGNESIUM RESULT WAS 0.8 MG/DL. THE PATIENT'S REPEAT MAGNESIUM RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844059 ↗