Cholestech LDX™ 14874 (REF 14874MR)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 00810039380512), received between Jan 23, 2026 and Jan 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Electrical Shock” (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.
Reports received per month
Most reported problems
Device problems
- Unintended Electrical Shock1
Patient problems
- Electric Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Unintended Electrical Shock
THE CUSTOMER REPORTED EXPERIENCING A BRIEF SHOCK WHEN USING THE CHOLESTECH LDX ANALYZER. THE CUSTOMER STATED THE SHOCK OCCURRED WHEN THEY TOUCHED THE RUN BUTTON TO INSERT A CASSETTE, AND COULD NOT VERIFY WHETHER IT WAS A STATIC SHOCK OR AN ELECTRICAL SHOCK. THE REPORTED SHOCK DID NOT LEAD TO AN INJURY OR OTHER ADVERSE HEALTH OUTCOME.
Patient problems: Electric Shock
MAUDE report 24171433 ↗
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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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