Pointe Scientific, Inc. H7545-CALRecalls & reported problems
Horiba Instruments Incorporated · Reagent for the calibration of Pointe Scientific’s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only. 1 x 3ml · Class 1
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
- Aug 10, 2018Class IIITerminated
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Z-0389-2019 · Root cause: Error in labeling · Recall details · FDA record ↗
Other Ldl & Vldl Precipitation, Hdl devices
- CardioChek® Plus Professional Analyzer 2700Polymer Technology Systems, Inc. · LDL & VLDL PRECIPITATION, HDL1 recall114 reports
- CardioChek® Plus Professional Analyzer, Refurbished 2702Polymer Technology Systems, Inc. · LDL & VLDL PRECIPITATION, HDL1 recall5 reports
- CardioChek 5700414Henry Schein, Inc. · LDL & VLDL PRECIPITATION, HDL1 recall0 reports
- LDL-Cholesterol Gen.3 07005768190Roche Diagnostics GmbH · LDL & VLDL PRECIPITATION, HDL6 reports
- LDL-Cholesterol Gen.3 08057966190Roche Diagnostics GmbH · LDL & VLDL PRECIPITATION, HDL5 reports
- LDL-Cholesterol Gen.3 07005717190Roche Diagnostics GmbH · LDL & VLDL PRECIPITATION, HDL5 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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