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U.S. Department of Health and Human Services

Class 2 Device Recall Alere Cholestech LDX System

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  Class 2 Device Recall Alere Cholestech LDX System see related information
Date Initiated by Firm November 16, 2010
Date Posted February 06, 2012
Recall Status1 Terminated 3 on August 22, 2013
Recall Number Z-0964-2012
Recall Event ID 60391
510(K)Number K901900  
Product Classification in vitro diagnostic - Product Code CHH
Product Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
Code Information ROM versions prior to 3.40
Recalling Firm/
Alere San Diego
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-455-4808 Ext. 3015
Manufacturer Reason
for Recall
Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability.
FDA Determined
Cause 2
Device Design
Action Alere sent an Updated Urgent Recall Notification Letter in March 2012 to all their customers who are in possession of one or more Cholestech LDX Systems. The updated letter provides the customers with important information about the problem identified and the actions to be taken. Customers are instructed to operate their device in a controlled environment that maintains humidity within 40-60% relative humidity if the device has not been upgraded with ROM pack v3.40. If humidity cannot be monitored, the device is no longer CLIA waived. Customers are instructed to complete the customer verification form. A previous notice from Alere sent in November 2010 instructs users to contact Alere to receive the ROM pack upgrade. Customers may email LDXROM@alere.com to request an electronic form to complete and return via email. Customers can expect their ROM packs approximately 10 to 14 business days after Alere receives their request. If customers have transferred ownership to another party, they can email Alere at LDXROM@alere.com with the updated contact information. If customers are not currently using their Cholestech LDX System, it is recommended that the ROM Pack upgrade be installed prior to restarting use of any Cholestech LDX analyzer. Customers with questions regarding this communication can call Alere at (877) 441-7440, option 1 or email at LDXROM@alere.com.
Quantity in Commerce 22,000 meters
Distribution Worldwide distribution including USA
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 = CHH and Original Applicant = CHOLESTECH CORP.