Cholestech LDX™ 14874 (UDI 00810039380307)Recalls & reported problems
Alere San Diego, Inc. · Cholestech LDX™ Analyzer · Class 1
All models of Cholestech LDX (5)
Data updated Oct 16, 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 00810039380307), received between Sep 26, 2023 and Sep 26, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Material Frayed1
- Sparking1
- Unintended Electrical Shock1
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.
MalfunctionSep 26, 2023Material Frayed; Sparking; Unintended Electrical Shock; Material Frayed; Sparking; Unintended Electrical Shock
THE CUSTOMER REPORTED OBSERVING SPARKS FROM THEIR FRAYED CHOLESTECH LDX ANALYZER POWER-SUPPLY DURING THE PERFORMANCE OF A HARD REBOOT. THE ANALYZER HAD NOT RECENTLY BEEN MOVED OR DROPPED AND THE ANALYZER WAS SET UP ON A DRY, STABLE SURFACE WITH NO OTHER INSTRUMENTS AROUND. TECHNICAL SERVICES ATTEMPTED TO GATHER ADDITIONAL INFORMATION ON THE LOCATION OF THE FRAY AND SPARK ON THE POWER SUPPLY, HOWEVER THE CUSTOMER COULD NOT PROVIDE ADDITIONAL DETAILS AND INDICATED THE POWER SUPPLY HAD BEEN DISCARDED. NO INJURY OR HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17821846 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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