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U.S. Department of Health and Human Services

Class 3 Device Recall Alere Cholestech LDX Lipid Profile"GLU Test Cassette

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  Class 3 Device Recall Alere Cholestech LDX Lipid Profile"GLU Test Cassette see related information
Date Initiated by Firm October 23, 2013
Date Posted November 22, 2013
Recall Status1 Terminated 3 on September 25, 2014
Recall Number Z-0379-2014
Recall Event ID 66663
510(K)Number K120615  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product 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.
Code Information Model Number: 10-991.  Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months.
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-805-2000 Ext. 3015
Manufacturer 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.
FDA Determined
Cause 2		 Labeling Change Control
Action 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.
Quantity in Commerce 3,621 kits
Distribution Worldwide Distribution: USA (nationwide) and Internationally to Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CGA and Original Applicant = ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
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