Cholestech LDXRecalls & reported problems across all models
Alere San Diego, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Cholestech LDX model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 5 models of Cholestech LDX by Alere San Diego, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2023 and Jan 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended Electrical Shock” (2 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Cholestech LDX recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 24, 2025Open, Classified
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1826-2025 · Root cause: Storage · Recall details · FDA record ↗
- Apr 24, 2025Open, Classified
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1825-2025 · Root cause: Storage · Recall details · FDA record ↗
- Apr 24, 2025Open, Classified
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1824-2025 · Root cause: Storage · Recall details · FDA record ↗
Most reported Cholestech LDX problems
Device problems
- Unintended Electrical Shock2
- Material Frayed1
- Sparking1
Patient problems
- Electric Shock1
- No Clinical Signs, Symptoms or Conditions1
Cholestech LDX models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cholestech LDX™ 88773Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- Cholestech LDX™ 97989Colorimetric Method, Triglycerides1 recall0 reports
- Cholestech LDX™ 97991Glucose Oxidase, Glucose1 recall0 reports
- Cholestech LDX™ 14874Analyzer, Chemistry, Micro, For Clinical Use1 report
- Cholestech LDX™ 14874Analyzer, Chemistry, Micro, For Clinical Use1 report
Recent Cholestech LDX adverse event reports
The 2 most recent reports across all models, 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 ↗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 ↗
Other Alere San Diego, Inc. products
All Alere San Diego, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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