DImension Vista® Immunoglobulin M Flex® reagent cartridge 10445904Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System · 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 00842768006197), received between Dec 26, 2018 and Dec 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (1 report).
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
- Low 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.
MalfunctionDec 26, 2018Low Test Results; Low Test Results
A DISCORDANT, FALSELY DEPRESSED IMMUNOGLOBULIN M (IGM) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED THE SAME DAY AND A HIGHER RESULT WAS OBTAINED AND A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IGM RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8197844 ↗
Other METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) devices
- AU OSR61173Beckman Coulter, Inc. · Method, Nephelometric, Immunoglobulins (G, A, M)1 recall0 reports
- IMMAGE 447610Beckman Coulter, Inc. · Method, Nephelometric, Immunoglobulins (G, A, M)1 recall0 reports
- Atellica CH IgM_2 11097620Siemens Healthcare Diagnostics Inc. · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 recall0 reports
- AU OSR61171Beckman Coulter, Inc. · Method, Nephelometric, Immunoglobulins (G, A, M)1 recall0 reports
- ADVIA® Chemistry IGM_2 Reagents 10309032Siemens Healthcare Diagnostics Inc. · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)2 reports
- VITROS 6801732Ortho-Clinical Diagnostics, Inc. · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 report
- Immunoglobulin M 20737771322Roche Diagnostics GmbH · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 report
- N Antisera to Human IgM 10446303Siemens Healthcare Diagnostics Products GmbH · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 report
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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