Alere Cholestech LDX® 99021Recalls & 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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 ↗
Other Glucose Oxidase, Glucose devices
- TRUEtrack TRUEtrack 50 Blood Glucose Test StripsTrividia Health, Inc. · Glucose Oxidase, Glucose153 reports
- HemoCue® Glucose 201 Microcuvettes 110706Hemocue AB · Glucose Oxidase, Glucose2 recalls0 reports
- VITROS 1707801Ortho-Clinical Diagnostics, Inc. · GLUCOSE OXIDASE, GLUCOSE1 recall48 reports
- Prodigy AutoCode Blood Glucose Monitoring System 051885Prodigy Diabetes Care, LLC · Glucose Oxidase, Glucose93 reports
- OneTouch Ultra Blue 022-895LifeScan U.S. LLC · GLUCOSE OXIDASE, GLUCOSE1 recall7 reports
- OneTouch Ultra Blue 020-994LifeScan U.S. LLC · GLUCOSE OXIDASE, GLUCOSE1 recall2 reports
- Alere Cholestech LDX® 10-991Alere San Diego, Inc. · Glucose Oxidase, Glucose1 recall1 report
- Cholestech LDX™ 97991Alere 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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page