Alere Cholestech LDX Multianalyte Controls Recalled for Incorrect Ranges
Alere San Diego is recalling Cholestech LDX Multianalyte Controls because the assigned control ranges for Total Cholesterol and Triglycerides are incorrect.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a labeling/range error in a quality control product rather than a direct patient safety hazard.
Plain-English summary
Alere San Diego, Inc. is recalling the Alere Cholestech LDX Multianalyte Controls, product numbers 88769 and 88773. These controls are used to monitor the performance of total cholesterol, high-density lipoprotein cholesterol, triglycerides, and glucose test procedures.
The recall is being conducted because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect. The affected units are identified by Lot C3091 and Lot C3091A. A total of 190 kits were distributed nationwide.
Users of these products should stop using the affected controls and contact Alere San Diego for further instructions.
The recalled product
- Product
- Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 190
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot C3091 and Lot C3091A
Distribution
Distributed nationwide across the United States.
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