Dimension Vista® Flex® reagent cartridge MG 10445158Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842768015694), received between May 18, 2018 and Feb 18, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K140790); they may or may not involve this specific model.

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.

Recalls naming this device

1. Nov 12, 2024Class IIOpen, Classified

   Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out

   Z-0767-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionFeb 18, 2022Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED MAGNESIUM (MG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATIVE DIMENSION VISTA SYSTEM AND A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS ADMINISTERED MAGNESIUM BASED ON THE DISCORDANT RESULT. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT MAGNESIUM RESULT OR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13558843 ↗
• MalfunctionFeb 18, 2022Low Test Results; Low Test Results

  FIFTEEN (15) DISCORDANT, FALSELY DEPRESSED MAGNESIUM (MG) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATIVE DIMENSION VISTA SYSTEM AND HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE WERE UNCONFIRMED REPORTS THAT MULTIPLE PATIENTS WERE TREATED BASED ON THE DISCORDANT RESULTS. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENTS DUE TO THE DISCORDANT MAGNESIUM RESULTS OR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13558842 ↗
• MalfunctionFeb 18, 2022Low Test Results; Low Test Results

  THIRTY-TWO (32) DISCORDANT, FALSELY DEPRESSED MAGNESIUM (MG) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATIVE DIMENSION VISTA SYSTEM AND HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE WERE UNCONFIRMED REPORTS THAT MULTIPLE PATIENTS WERE TREATED BASED ON THE DISCORDANT RESULTS. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENTS DUE TO THE DISCORDANT MAGNESIUM RESULTS OR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13558841 ↗
• MalfunctionFeb 18, 2022Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED MAGNESIUM (MG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATIVE DIMENSION VISTA SYSTEM AND A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS ADMINISTERED A MAGNESIUM SUPPLEMENT BASED ON THE DISCORDANT RESULT. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT MAGNESIUM RESULT OR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13558840 ↗
• MalfunctionMay 18, 2018Low Test Results; Low Test Results

  DISCORDANT, ABNORMAL ASSAY ERROR FLAGGED, FALSELY DEPRESSED MAGNESIUM (MG) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN REQUESTED NEW SAMPLES FROM THE PATIENTS. THE NEW SAMPLES WERE PROCESSED AND HIGHER RESULTS WERE OBTAINED. THE ORIGINAL SAMPLES WERE PROCESSED AGAIN AT A LATER DATE AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER STATED THAT BOTH PATIENTS RECEIVED TREATMENT HOWEVER, THERE WAS NO INDICATION OF THE TYPE OF TREATMENT RECEIVED. (COMPLAINT STATES: FLOOR NURSE INDICATED THE PATIENT WAS TREATED FOR THE LOW MG BUT DID NOT * ELABORATE ON THE TREATMENT.) THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ABNORMAL ASSAY ERROR FLAGGED, FALSELY DEPRESSED MAGNESIUM (MG) RESULTS OR TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7526057 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140790. One submission often covers many models, so check the product and lot details in each record.

• Z-0830-2022 · Jan 28, 2022 · Open, Classified
  Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent