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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 Cassettesee related information
Date Initiated by FirmOctober 23, 2013
Date PostedNovember 22, 2013
Recall Status1 Terminated 3 on September 25, 2014
Recall NumberZ-0379-2014
Recall Event ID 66663
510(K)NumberK120615 
Product Classification Glucose oxidase, glucose - Product Code CGA
ProductProduct 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
ActionAlere 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 Commerce3,621 kits
DistributionWorldwide Distribution: USA (nationwide) and Internationally to Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CGA
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