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U.S. Department of Health and Human Services

Class 3 Device Recall Alere Cholestech LDX Multianalyte Controls

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  Class 3 Device Recall Alere Cholestech LDX Multianalyte Controls see related information
Date Initiated by Firm August 27, 2015
Date Posted October 15, 2015
Recall Status1 Terminated 3 on December 22, 2015
Recall Number Z-0122-2016
Recall Event ID 72120
510(K)Number K102700  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product 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.
Code Information Lot C3091 and Lot C3091A
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 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.
FDA Determined
Cause 2		 Error in labeling
Action Customer notification letters dated 8/25/15 and 9/3/15 were sent to customers to inform them that 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. Customers are informed that the Alere Cholestech LDX Total Cholesterol and Triglyceride assays continue to perform as expected. However, if customers' facility has used the control lot to test Total Cholesterol or Triglycerides as part of their Quality Control program, Alere San Diego recommends that they verify previous results or perform control testing using the replacement Expected Value Card or replacement control materials. The letters also provide customers with actions to be taken. Customers with questions are instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121 U.S.A. Phone: 877-308-8289, FAX: 866-333-9839, E-mail: Verifications.ts@alere.com.
Quantity in Commerce 190 kits
Distribution Nationwide Distribution.
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 = JJY and Original Applicant = ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN
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