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U.S. Department of Health and Human Services

Class 2 Device Recall Cholestech LDX Lipid Controls

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  Class 2 Device Recall Cholestech LDX Lipid Controls see related information
Date Initiated by Firm October 06, 2010
Date Posted November 22, 2010
Recall Status1 Terminated 3 on August 01, 2012
Recall Number Z-0442-2011
Recall Event ID 56985
510(K)Number K913687  
Product Classification Multi-Analyte Controls - Product Code JJY
Product Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983.

Assayed quality control material for use with the Cholestech LDX System.
Code Information Lot # SC0146
Recalling Firm/
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 because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.
FDA Determined
Cause 2
Action All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010. Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice. Consignees with questions about the information contained in the notification were instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121 U.S.A. Phone: 877 441 7440 FAX: 858 805 8457 E-mail: Response.ts@alere.com
Quantity in Commerce 917 kits
Distribution Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.
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 = STRECK LABORATORIES, INC.