Alere San Diego, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0379-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: October 23, 2013

Date Posted: December 4, 2013

Recall Number: Z-0379-2014

Event ID: 66663

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3,621 kits

Code Information:

Model Number: 10-991. Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months.

Distribution Pattern:

Worldwide Distribution: USA (nationwide) and Internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated