Dimension Vista®/Dimension® EXL™ CTNI SDIL 10445205Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · CTNI Sample Diluent, 6x2.5mL · 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 00842768015892), received between Mar 28, 2018 and Mar 28, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K081643); 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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2018High Test Results; High Test Results
A DISCORDANT ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE ORIGINAL SAMPLE WAS REPEATED AND A LOWER RESULT WAS OBTAINED. A CORRECTED RESULT WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED CTNI RESULT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7377869 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K081643. One submission often covers many models, so check the product and lot details in each record.
- Z-2436-2018 · Mar 21, 2018 · TerminatedDimension Vista CTNI Sample Diluent, KD692, SMN# 10445205
- Z-2606-2017 · Mar 21, 2017 · TerminatedDimension Troponin 1 (TNI) Flex reagent cartridge
- Z-0069-2012 · Aug 31, 2011 · TerminatedSiemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
- Z-0460-2011 · Apr 12, 2010 · TerminatedThe Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
Other IMMUNOASSAY METHOD, TROPONIN SUBUNIT devices
- i-STAT 03P90-25Abbott Point Of Care Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT474 reports
- Atellica IM TNIH 10997841Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT463 reports
- Access hsTnI B52669Beckman Coulter, Inc. · Immunoassay Method, Troponin Subunit2 recalls170 reports
- i-STAT 06P23-25Abbott Point Of Care Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT195 reports
- VITROS 6802301Ortho Clinical Diagnostics · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall139 reports
- Atellica IM TNIH 10997840Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT166 reports
- Dimension EXL LOCI Troponin I High Sensitive 10471068Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall76 reports
- Access AccuTnI+3 A98143Beckman Coulter, Inc. · Immunoassay Method, Troponin Subunit1 death106 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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