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U.S. Department of Health and Human Services

Class 2 Device Recall Cholestech LDX Lipid Profile"GLU test cassettes

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  Class 2 Device Recall Cholestech LDX Lipid Profile"GLU test cassettes see related information
Date Initiated by Firm February 18, 2011
Date Posted June 01, 2011
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-2402-2011
Recall Event ID 58557
510(K)Number K904082  
Product Classification Glucose oxidase, Glucose - Product Code CGA
Product Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104

Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (lowdensity lipoprotein) and non-HDL cholesterol are calculated by the Cholestech LDX.
Code Information Lot # 245104
Recalling Firm/
Manufacturer		 Biosite Inc Dba Innovacon Inc.
9975 Summers Ridge Rd
San Diego CA 92121
For Additional Information Contact
858-455-4808 Ext. 3015
Manufacturer Reason
for Recall		 The recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 mg/dL regardless of the true value of the specimen.
FDA Determined
Cause 2		 Pending
Action Alere San Diego, Inc ( formerly known as Biosite Incorporated sent an URGENT MEDICAL DEVICE RECALL letter on February 18, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were requested to: (1) Discontinue use and/or sale of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 245104. (2) Discard in accordance with your local regulations, all units of the above listed product. (3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. (4) If you have forwarded the product listed above to another laboratory, please provide a copy of this letter to them. (5) Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice, to indicate the number of boxes of test cassettes discarded from your inventory and replacement product will be sent to you. For questions about the information contained in this notification, customers were instructed to contact Alere Technical Services at 1-877-308-8289 (24 hours a day, 7 days a week) or via e-mail at service.cholestech@alere.com.
Quantity in Commerce 5,305 Boxes
Distribution Worldwide Distribution - USA ( nationwide ) including the countries of South America ( EL Salvador) , Europe ( Denmark, France, Norway and Switzerland), Bahrain, Kuwait, South Africa, and United Arab Emirates.
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 = CHOLESTECH CORP.
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