Alere San Diego, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0122-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: August 27, 2015

Date Posted: October 21, 2015

Recall Number: Z-0122-2016

Event ID: 72120

Reason for Recall:

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.

Status: Terminated

Product Quantity: 190 kits

Code Information:

Lot C3091 and Lot C3091A

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated