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Alere Cholestech LDXRecalls & reported problems across all models

Alere San Diego, Inc. · 6 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names at least one Alere Cholestech LDX model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls
1

We found 6 models of Alere Cholestech LDX by Alere San Diego, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Dec 11, 2020 and Dec 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 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

Alere 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.

  1. Jun 24, 2022Open, Classified

    Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).

    Z-1508-2022 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗

Most reported Alere Cholestech LDX problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • Insufficient Information1

Alere Cholestech LDX models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Alere Cholestech LDX adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Alere San Diego, Inc. products

All Alere San Diego, Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page