Magnesium Gen2 6481647190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04015630929818), received between Oct 29, 2021 and Aug 18, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298818 ↗
• MalfunctionOct 23, 2023Mechanical Problem; High Test Results; Mechanical Problem; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH MAGNESIUM GEN.2 (MG2) ASSAY ON A COBAS 6000 C501 ANALYZER. INITIAL RESULT: 2.01 MMOL/L. NO QUESTIONABLE RESULT WAS RELEASED OUTSIDE OF THE LABORATORY AS THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. AND THE SAMPLE WAS REPEATED. RERUN RESULT: 0.83 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17988977 ↗
• MalfunctionJun 5, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE MG2 MAGNESIUM GEN.2 RESULTS FOR 3 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULTS AND THE SAMPLES WERE REPEATED. FOR PATIENT 1, THE INITIAL MG2 RESULT WAS 4.3 MG/DL. THE REPEAT RESULT WAS 2.0 MG/DL. THE SAMPLE WAS REPEATED AGAIN USING A NEW REAGENT PACK AND THE RESULT WAS 1.9 MG/DL. FOR PATIENT 2, THE INITIAL MG2 RESULT WAS 4.2 MG/DL. THE REPEAT RESULT WAS 1.8 MG/DL. THE SAMPLE WAS REPEATED AGAIN USING A NEW REAGENT PACK AND THE RESULT WAS 1.6 MG/DL. FOR PATIENT 3, THE INITIAL MG2 RESULT WAS 4.5 MG/DL. THE REPEAT RESULT WAS 2.4 MG/DL. THE SAMPLE WAS REPEATED AGAIN USING A NEW REAGENT PACK AND THE RESULT WAS 2.1 MG/DL. THE FIRST REPEAT RESULTS WERE DEEMED CORRECT. THE ANALYZER SERIAL NUMBER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17065971 ↗
• MalfunctionApr 10, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR MG2 MAGNESIUM GEN.2 (MG2) ON A COBAS 4000 C (311) STAND ALONE SYSTEM. THE INITIAL RESULT FROM THE C311 SYSTEM WAS 0.9 MG/DL. THE REPEAT RESULT FROM THE SAME SYSTEM WAS 1 MG/DL. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY AND THE RESULT FROM AN UNKNOWN METHOD WAS 1.9 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE C311 ANALYZER SERIAL NUMBER WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709615 ↗
• MalfunctionNov 17, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE MG2 MAGNESIUM GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS MODULE. FOR PATIENT ID (B)(6), THE INITIAL MG2 RESULT WAS 3.4 MG/DL. THE REPEAT RESULT WAS 2.0 MG/DL. FOR PATIENT ID (B)(6), THE INITIAL MG2 SERUM RESULT WAS 3.5 MG/DL. THE REPEAT SERUM RESULT WAS 2.2 MG/DL. THE CUSTOMER ALSO PERFORMED MG2 TESTING ON A PLASMA SAMPLE FROM THE SAME PATIENT. THE RESULT MATCHED THE REPEAT SERUM RESULT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT. THE MG2 REAGENT LOT NUMBER IS 62758601 AND THE EXPIRATION DATE IS 31-DEC-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15817473 ↗
• MalfunctionMar 28, 2022Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE RESULTS FOR MULTIPLE PATIENTS TESTED FOR MG2 ON A COBAS 6000 C (501) MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 3.9 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED. THE REPEAT RESULT WAS 2.2 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE MG2 REAGENT LOT NUMBER WAS 596601. THE EXPIRATION DATE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929974 ↗
• MalfunctionOct 29, 2021Degraded; High Test Results; Degraded; High Test Results

  THE INITIAL REPORTER STATED THEY HAD ISSUES WITH CONTROL RECOVERY FOR MG2 MAGNESIUM GEN.2 ON A COBAS 6000 C (501) MODULE. QUALITY CONTROLS WERE ACCEPTABLE AT THE BEGINNING OF THE SHIFT, BUT ON THE NEXT SHIFT, THEY WERE UNACCEPTABLE. WHEN QC FAILED, THE MAGNESIUM REAGENT KIT HAD ABOUT 10 TESTS LEFT. THIS KIT WAS RECALIBRATED, BUT CONTROLS STILL FAILED. THE CUSTOMER DISCARDED THE REAGENT KIT AND LOADED A NEW KIT THAT HAD SUCCESSFUL QC. 13 PATIENT SAMPLES WERE REPEATED ON (B)(6) 2021 USING THE NEW REAGENT KIT BECAUSE THE INITIAL RESULTS WERE HIGHER THAN EXPECTED. OF THE THIRTEEN SAMPLES, TEN SAMPLES HAD DISCREPANT MAGNESIUM VALUES. THE INITIAL VALUES FOR THESE SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY AND THE REPEAT VALUES WERE BELIEVED TO BE CORRECT. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SERIAL NUMBER OF THE C 501 ANALYZER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724244 ↗