Dimension® EXL™ LOCI® Module Flex® reagent cartridge NTP 10464526Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · LOCI N-terminal Pro-Brain Natriuretic Peptide Flex® reagent cartridge, 120 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 00842768029912), received between Aug 11, 2025 and Aug 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (1 report).
1 other recall cover devices cleared under the same FDA submission (K082645); 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.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED THAT AN ERRONEOUSLY DEPRESSED N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (NT-PROBNP) RESULT WAS OBTAINED ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED THRICE ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND OBTAINED HIGHER RESULTS. THE REPEAT RESULTS MATCHED THE PATIENT¿S CLINICAL HISTORY, AND ONE OF THE RESULTS WAS REPORTED TO THE PHYSICIAN(S) AS CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS NT-PROBNP RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769107 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K082645. One submission often covers many models, so check the product and lot details in each record.
- Z-0461-2011 · Apr 12, 2010 · TerminatedThe Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro- Brain Natriuretic Peptide and N-Terminal Pro brain Natriuretic Peptide (low volume)
Other TEST,NATRIURETIC PEPTIDE devices
- PATHFAST NTproBNP N/APhc Corporation · Test,Natriuretic Peptide1 recall0 reports
- VITROS 6192255Ortho Clinical Diagnostics · Test, natriuretic peptide18 reports
- Elecsys proBNP II Immunoassay 09315284190Roche Diagnostics GmbH · Test, natriuretic peptide8 reports
- Elecsys proBNP II Immunoassay 09315268160Roche Diagnostics GmbH · Test, natriuretic peptide5 reports
- VITROS 6802156Ortho Clinical Diagnostics · TEST,NATRIURETIC PEPTIDE3 reports
- Elecsys proBNP II STAT Immunoassay 09315276160Roche Diagnostics GmbH · Test, natriuretic peptide2 reports
- i-STAT 03P93-25Abbott Point Of Care Inc. · TEST,NATRIURETIC PEPTIDE2 reports
- Access BNP 98200Beckman Coulter, Inc. · Test, Natriuretic Peptide2 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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