Dimension Vista® Flex® reagent cartridge MMB 10445097Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 100 tests · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768015328), received between Oct 30, 2018 and Oct 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
5 other recalls cover devices cleared under the same FDA submission (K143720); 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
Device problems
- High Test Results1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2018High Test Results; High Test Results
A DISCORDANT MASS CREATINE KINASE MB ISOENZYME (MMB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED THE SAME DAY AND A CORRECT RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. NO TREATMENT WAS PROVIDED TO THE PATIENT ON THE BASIS OF THE REPORTED DISCORDANT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED MMB RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8018896 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143720. One submission often covers many models, so check the product and lot details in each record.
- Z-0330-2022 · Oct 15, 2021 · TerminatedDimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determi
- Z-0331-2022 · Oct 15, 2021 · TerminatedDimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determi
- Z-1015-2019 · Dec 12, 2018 · TerminatedDimension Vista 1500, Analyzer, chemistry Model no. 10444801
- Z-0617-2019 · Oct 16, 2018 · TerminatedDimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral
- Z-1672-2018 · Jan 2, 2018 · TerminatedDimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge
Other COLORIMETRIC METHOD, CPK OR ISOENZYMES devices
- Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge 10444904Siemens Healthcare Diagnostics Inc. · COLORIMETRIC METHOD, CPK OR ISOENZYMES5 reports
- Elecsys CK-MB 07027087190Roche Diagnostics GmbH · COLORIMETRIC METHOD, CPK OR ISOENZYMES3 reports
- Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge 10444895Siemens Healthcare Diagnostics Inc. · COLORIMETRIC METHOD, CPK OR ISOENZYMES2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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