Dimension® TNI CAL 10464336Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · LOCI Cardiac Troponin I Calibrator, 2x5x2mL · 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 00842768022074), received between May 11, 2020 and May 11, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K081683); 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.
MalfunctionMay 11, 2020High Test Results; High Test Results
DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN WHEN OUT OF RANGE DAILY QUALITY CONTROL (QC) WAS NOTED. THE SAME SAMPLES WERE REPROCESSED THE SAME DAY OR THE NEXT DAY ON THE SAME INSTRUMENT AS WELL AS ON AN ALTERNATE DIMENSION INSTRUMENT, LOWER CORRECT RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10045167 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K081683. One submission often covers many models, so check the product and lot details in each record.
- Z-1926-2014 · Sep 17, 2013 · TerminatedSiemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TN
- Z-0513-2012 · Nov 17, 2011 · TerminatedSiemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
- Z-0038-2012 · Aug 31, 2011 · TerminatedDimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on t
Other CALIBRATOR, SECONDARY devices
- ARCHITECT 2K41-27Abbott Laboratories · CALIBRATOR, SECONDARY1 recall374 reports
- ARCHITECT 8K28-02Abbott Laboratories · CALIBRATOR, SECONDARY1 recall115 reports
- BioPlex 2200 12000651Bio-Rad Laboratories, Inc. · Calibrator, secondary3 recalls0 reports
- VITROS 8231474Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary3 recalls0 reports
- ARCHITECT 08K2803Abbott GmbH · Calibrator, secondary1 recall93 reports
- ARCHITECT 7K63-25Abbott Ireland · CALIBRATOR, SECONDARY108 reports
- VITROS 8067324Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary2 recalls0 reports
- VITROS 8568040Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, SECONDARY1 recall18 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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