Dimension Vista® Flex® reagent cartridge CKI 10464356Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768027925), received between Nov 8, 2018 and Feb 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K083465); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED SIX (6) ERRONEOUS CREATINE KINASE (CKI) RESULTS ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED TWICE WITH AUTO DILUTION AND THRICE WITH MANUAL DILUTION ON THE ORIGINAL DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM. THE REPROCESSED RESULTS OBTAINED WERE HIGHER AND CONSIDERED ERRONEOUS. THE SAME SAMPLE WAS REPROCESSED WITH 1:231 MANUAL DILUTION ON THE ORIGINAL DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM AND A RESULT OBTAINED WAS HIGHER THAN THE INITIAL RESULT AND LOWER THAN THE OTHER REPROCESSED RESULTS. THE REPROCESSED RESULT WITH 1:231 MANUAL DILUTION WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CREATINE KINASE (CKI) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320856 ↗
• MalfunctionNov 8, 2018Low Test Results; Low Test Results

  A DISCORDANT, BELOW ASSAY RANGE, CREATINE KINASE (CKI) RESULT WAS REPORTED FOR A PATIENT SAMPLE FROM A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS PROVIDED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED THE SAME DAY WITH A DILUTION AND A HIGHER, CORRECT RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. NO TREATMENT WAS PROVIDED TO THE PATIENT ON THE BASIS OF THE REPORTED DISCORDANT CKI RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CKI RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8053079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083465. One submission often covers many models, so check the product and lot details in each record.

• Z-1659-2018 · Jun 29, 2017 · Terminated
  Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)