Magnesium Gen.2 08058016190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613336121412), received between Dec 5, 2023 and Aug 3, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 16, 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 3, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122205 ↗
• MalfunctionDec 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER ALLEGED THERE WAS INTERFERENCE FROM THE PATIENT'S MEDICATIONS. THIS MEDWATCH IS FOR THE MAGNESIUM GEN.2 ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER PT-0081788 FOR THE CALCIUM GEN.2 ASSAY. PATIENT 1: THE INITIAL MAGNESIUM GEN.2 RESULT WAS 0.149 MG/DL, AND THE INITIAL CALCIUM GEN.2 RESULT WAS - 0.101 MG/DL. THIS PATIENT WAS BEING TREATED WITH ISOPRINOSINE. THE SAMPLE WAS REPEATED USING A COBAS C501, AND THE MAGNESIUM RESULT WAS 0.544 MG/DL. THE CALCIUM RESULT WAS -0.0693 MG/DL. PATIENT 2: THE INITIAL MAGNESIUM RESULT WAS 0.218 MG/DL, AND THE INITIAL CALCIUM WAS 1.18 MG/DL. THIS PATIENT WAS BEING TREATED WITH CORTIZON. THE SAMPLE WAS REPEATED USING A COBAS C501, AND THE MAGNESIUM RESULT WAS 0.214 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679885 ↗
• MalfunctionSep 15, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE MAGNESIUM GEN.2 RESULTS FOR SEVERAL PATIENT SAMPLES ON A COBAS C 303 ANALYTICAL UNIT. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 1 PATIENT PLASMA SAMPLE. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLES AS THEY WERE ACCOMPANIED BY CRITICAL FLAGS APPLIED BY THE MIDDLEWARE. THE INITIAL MAGNESIUM RESULT WAS 3.9 MG/DL. THE REPEAT RESULT WAS 1.8 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057774 ↗
• MalfunctionMar 18, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE MAGNESIUM GEN.2 RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 3.11 MG/DL. THE REPEAT RESULT WAS 2.1 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630898 ↗
• MalfunctionJul 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT PLASMA SAMPLE TESTED WITH MAGNESIUM GEN.2 (MG2) ASSAY ON A COBAS C303 ANALYTICAL UNIT. ON (B)(6) 2024: INITIAL RESULT: THE EXACT VALUE WAS NOT PROVIDED BUT IT WAS MENTIONED TO BE "1. SOMETHING" MG/DL AND WAS CONSIDERED CRITICAL. 1ST REPEAT RESULT: 2.1 MG/DL (AUTO-RUN). THIS RESULT WAS REPORTED TO THE PROVIDER. THE ORIGINAL SAMPLE WAS THEN REPEATED AND THE 2ND REPEAT RESULT WAS 1.2 MG/DL. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT OF 1.2 MG/DL WAS ISSUED AND REPORTED TO THE PROVIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19683767 ↗
• MalfunctionFeb 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE CUSTOMER ALLEGED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE MAGNESIUM REAGENT ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL VALUES WERE REPORTEDLY QUESTIONED BY THE CUSTOMER AND THE SAMPLES WERE REPEATED. THE REPEAT VALUES WERE DEEMED CORRECT BY THE CUSTOMER. THE FIRST SAMPLE REPORTEDLY RESULTED IN AN INITIAL MAGNESIUM VALUE OF 2.0 MG/DL AND IT REPEATED AS 1.1 MG/DL. THE SECOND SAMPLE REPORTEDLY RESULTED IN AN INITIAL MAGNESIUM VALUE OF 2.6 MG/DL AND IT REPEATED AS 1.8 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627451 ↗
• MalfunctionDec 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 AND MG2 MAGNESIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL CALCIUM RESULT WAS 3.12 MG/DL AND THE INITIAL MG2 RESULT WAS 0.659 MG/DL. THE DOCTOR QUESTIONED THE RESULTS AND THE SAMPLE WAS REPEATED. THE REPEAT CALCIUM RESULT WAS 8.21 MG/DL AND THE REPEAT MG2 RESULT WAS 1.34 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267555 ↗