Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Alere Cholestech LDX Multianalyte Controls Recalled by Alere San Diego, Inc. Due to Alere San Diego is recalling the Alere Cholestech...

Date: August 27, 2015
Company: Alere San Diego, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alere San Diego, Inc. directly.

Affected Products

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.

Quantity: 190 kits

Why Was This Recalled?

Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Alere San Diego, Inc.

Alere San Diego, Inc. has 49 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report