Dimension Vista® Flex® reagent cartridge CA15-3 10464344Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842768028526), received between Aug 4, 2022 and Aug 4, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K100344); 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Low Test Results; Low Test Results

  A CUSTOMER REPORTED THAT THEY NOTICED A SHIFT LOW IN RESULTS WHEN DOING PATIENT CORRELATIONS TESTING FOR CANCER ANTIGEN 15-3 (CA15-3) ON THE DIMENSION VISTA® 1500 SYSTEM, SERIAL NUMBER (B)(4). PATIENT CORRELATION SAMPLE RESULTS WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165540 ↗
• MalfunctionAug 4, 2022High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER REPORTED THAT THEY NOTICED A SHIFT IN RESULTS WHEN DOING PATIENT CORRELATIONS TESTING FOR CANCER ANTIGEN 15-3 (CA15-3) ON THE DIMENSION VISTA® 500 SYSTEM, SERIAL NUMBER (B)(4). PATIENT CORRELATION SAMPLE RESULTS WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165518 ↗
• MalfunctionAug 4, 2022Low Test Results; Low Test Results

  A CUSTOMER REPORTED THAT THEY NOTICED A SHIFT LOW IN RESULTS WHEN DOING PATIENT CORRELATIONS TESTING FOR CANCER ANTIGEN 15-3 (CA15-3) ON THE DIMENSION VISTA® 500 SYSTEM, SERIAL NUMBER: (B)(4). PATIENT CORRELATION SAMPLE RESULTS WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165497 ↗
• MalfunctionAug 4, 2022Low Test Results; Low Test Results

  A CUSTOMER REPORTED THAT THEY NOTICED A SHIFT LOW IN RESULTS WHEN DOING PATIENT CORRELATIONS TESTING FOR CANCER ANTIGEN 15-3 (CA15-3) ON THE DIMENSION VISTA® 500 SYSTEM, SERIAL NUMBER (B)(4). PATIENT CORRELATION SAMPLE RESULTS WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165486 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100344. One submission often covers many models, so check the product and lot details in each record.

• Z-1648-2022 · Jul 18, 2022 · Open, Classified
  Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344