Alere Cholestech LDX® 10-991Recalls & reported problems
Alere San Diego, Inc. · Alere Cholestech LDX® Lipid Profile GLU · Class 2
All models of Alere Cholestech LDX (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00893038002654), 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 this device's 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, 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
- Jun 24, 2022Class IIOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2020 A PATIENT HAVING A WELLNESS CHECK HAD A DISCREPANCY WITH LDX RESULTS DISPLAYING N/A, SPECIFICALLY TC, NON HDL, TC/HDL AND LDL. THE TEST WAS RERUN WITH THE SAME SAMPLE AND LOT ALTHOUGH A DIFFERENT CASSETTE WITH DIFFERENT RESULTS. THERE WAS NO LAB/CONFIRMATORY TESTING PROVIDED. (ALL RESULTS IN MG/DL). THERE WAS NO ADVERSE EVENT REPORTED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN PROVIDED. TEST 1: TC:N/A; TRG:289; HDL:<15; NON-HDL: N/A; TC/HDL: N/A; LDL: N/A; GLUCOSE:178 TEST 2: TC:166; TRG: 186; HDL: 51; NON-HDL: NOT PROVIDED; TC/HDL: NOT PROVIDED; LDL: 78; GLUCOSE:64
Patient problems: Insufficient Information
MAUDE report 10993890 ↗
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- Cholestech LDX™ 97991Alere San Diego, Inc. · Glucose Oxidase, Glucose1 recall0 reports
- Alere Cholestech LDX® 99021Alere San Diego, Inc. · Glucose Oxidase, Glucose1 recall0 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 · each report above links to its original FDA record
- 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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