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U.S. Department of Health and Human Services

Class 3 Device Recall Alere Cholestech LDX Multianalyte Control

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 Class 3 Recall
Alere Cholestech LDX Multianalyte Control
see related information
Date Posted January 29, 2013
Recall Status1 Terminated on September 26, 2013
Recall Number Z-0746-2013
Recall Event ID 63918
Premarket Notification
510(K) Number
K102700 
Product Classification Multi-Analyte Controls, All Kinds (Assayed) - Product Code JJY
Product Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.
Code Information Lot#C2510, C2510A, C2572, C2572A, C2593, and C2593A.
Recalling Firm/
Manufacturer
Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego, California 92121-2997
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Out of range (increased) HDL Cholesterol results.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action A recall letter was sent on 10/22/12 to all customers who purchased the Alere Cholestech LDX Mutianalyte Control, 2 vial set, Catalog Number 88769, Lot #C2510 & Lot #C2510A. The letter informed the customers that these lots of controls may yield results which are out of range high for the Level 2 control when tested with the Alere Cholestech LDX HDL test. Customers are instructed of the actions to be taken. On 11/16/12, the recall expanded to include the Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog 88770, Lot#271097. The problem identified is that these lots of calibration verification materials may yield results which are out of range high when tested with the Alere Cholestech LDX HDL test. Customers are instruted of the actions to be taken. On 3/6/13, the recall expanded to include the Alere Cholestech LDX Calibration Verification, 4 Vial set, Catalog # 88770, Lot#298148 and 301886. The recall expanded to include the Alere Cholestech LDX Multianalyte Control, 2 vial Set, Catalog # 88769, Lots#C2572, C2572A, C2593 and C2593A. Customers are instructed to complete and fax the enclosed verification form within 10 days. Customers with questions are instructed to contact Alere San Diego, 9975 Summers Ridge Rd, San Diego, CA 92121, (877) 308-8289, fax (858) 805-8457, and responses.ts@alere.com.
Quantity in Commerce 11,166 kits
Distribution Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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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