Class III — Low Risk

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

Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette Recalled by Alere San Diego, Inc. Due to Alere initiated a recall of Cholestech LDX Lipid...

Date: October 23, 2013
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

Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.

Quantity: 3,621 kits

Why Was This Recalled?

Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067.

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