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U.S. Department of Health and Human Services

Class 3 Device Recall Cholestech LDX High Sensitivity CReactive Protein (hsCRP) Test Cassette

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  Class 3 Device Recall Cholestech LDX High Sensitivity CReactive Protein (hsCRP) Test Cassette see related information
Date Initiated by Firm August 09, 2006
Date Posted September 20, 2008
Recall Status1 Terminated 3 on September 30, 2009
Recall Number Z-2457-2008
Recall Event ID 49142
510(K)Number K040579  
Product Classification Vanilmandelic acid test system. - Product Code DCK
Product Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.
Code Information Catalog #12-807, Lot #C17-6434
Recalling Firm/
Manufacturer		 Cholestech Corp
3347 Investment Blvd
Hayward CA 94545-3808
For Additional Information Contact
510-732-7200
Manufacturer Reason
for Recall		 Test results are high, outside of control material upper limit specification. Results could be as high as 15%.
FDA Determined
Cause 2		 Device Design
Action Cholestech provided its three distributors a notification letter/response form with instructions to distribute the letter to their customers/end users dated August 9, 2006. The letter instructed customers to discontinue use of the lot of cassettes, return remaining cassettes to Cholestech through the Technical Service Representative and to complete and return the response form. The end users returned the signed letters directly to Cholestech so that effectiveness checks could be completed.
Quantity in Commerce 2, 910 cassettes
Distribution Nationwide Distribution --- including states of Virginia, Texas and North Carolina, Ohio, Arkansas, Washington, Florida , California and Michigan.
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 = DCK and Original Applicant = CHOLESTECH CORP.
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