Dimension Vista® LOCI 8 CAL 10488192Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · LOCI 8 Calibrator, 2x5x2.5mL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Nov 9, 2017Class IITerminated
An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.
Z-1184-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other CALIBRATOR, MULTI-ANALYTE MIXTURE devices
- CAL 3 CAL2351Randox Laboratories Limited · Calibrator, Multi-Analyte Mixture6 recalls0 reports
- VITROS 6844508Ortho-Clinical Diagnostics, Inc. · Calibrator, multi-analyte mixture2 recalls7 reports
- SP CAL (LIQ) IT2691Randox Laboratories Limited · Calibrator, Multi-Analyte Mixture2 recalls0 reports
- VITROS 1662659Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall17 reports
- RAPIDPoint® 500 Measurement Cartridge 10491449Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall3 reports
- ADVIA® Chemistry Calibrator 10312279Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall3 reports
- ADVIA® Chemistry CardioPhase™ hsCRP Calibrators 10335897Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall0 reports
- ADVIA® Chemistry ToxAmmonia Cal 10309217Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall0 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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