Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere C

FDA device recall Z-0379-2014 · posted 2013-11-22 · Terminated

Recall details

Recalling firm

Alere San Diego, Inc.

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.

Action taken

Alere initiated this recall by sending out notification letters to customers via fax, email, or direct mail. The letter titled "URGENT MEDICAL DEVICE NOTICE", dated October 23, 2013 is accompanied by a response form/Verification form. The notification informed customers of the reason for recall, product description with codes, required actions by the customers, and contact information.

Root cause

Labeling Change Control

Status

Terminated

Product code

CGA

Quantity affected

3,621 kits

Distribution

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

Date initiated

2013-10-23

Date posted

2013-11-22

Date terminated

2014-09-25

Location

San Diego, CA

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