Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1508-2022·Announced 2022-08-17

Cholestech LDX cholesterol test cassettes require bilirubin interference label update

Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: This is a Class II recall focused on a package insert update regarding a documented analytical limitation (bilirubin interference affecting test accuracy). No illnesses, injuries, or reported failures are mentioned. Per the rubric, labeling updates for precautionary purposes without reported harm fall under the Moderate category.

Plain-English summary

The Cholestech LDX System is a point-of-care diagnostic device that measures total cholesterol, HDL cholesterol, triglycerides, and glucose using fingerstick whole blood or venipuncture samples. Alere San Diego, Inc. is issuing a recall to update the product package insert with information about bilirubin interference.

Samples containing bilirubin at concentrations greater than 2.0 mg/dL (conjugated form) or 1.6 mg/dL (unconjugated form) can result in reduced recovery of triglyceride and HDL measurements. This means test results may be inaccurately low when bilirubin levels exceed these thresholds.

Approximately 436,990 cassettes have been distributed across the United States and internationally. The recall affects all lot numbers of Cholestech LDX Lipid Profile, TC HDL, and related cassettes.

Alere has classified this as a Class II recall and is requiring package insert updates to disclose the bilirubin interference limitation. Healthcare providers should review the updated labeling when interpreting test results, particularly in patients with elevated bilirubin.

The recalled product

Product: The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube)…
Manufacturer: Alere San Diego, Inc.
Category: Medical Device — Diagnostic Test System
Hazard: inaccurate-results
bilirubin-interference
mis-labeling
Affected units: 436,990

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 (6)

All lots of Part/UDI-DI: 10-991/00893038002654
99021/00899722002344
14-531/04571226470831
10-990/00893038002647
10-989/00893038002630
10-987/00893038002616

Distribution

Distributed in 31 states:

Same manufacturer · Alere San Diego, Inc.

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