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U.S. Department of Health and Human Services

Class 2 Device Recall Alere Cholestech LDX hsCRP Test Cassette,

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 Class 2 Recall
Alere Cholestech LDX hsCRP Test Cassette,
see related information
Date Posted April 25, 2013
Recall Status1 Terminated on March 12, 2014
Recall Number Z-1178-2013
Recall Event ID 64701
Premarket Notification
510(K) Number
K040579 
Product Classification C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
Product The Alere Cholestech LDX® high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX® high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
Code Information Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13
Recalling Firm/
Manufacturer
Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego, California 92121-2997
Manufacturer Reason
for Recall
The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Alere sent an Urgent Medical Device Recall letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to block all stock of the affected lot in their warehouses; discontinue use and discard all stock on hand, complete the provided Customer Verification form to document disposal, contact their primary consignees and advise them of the required discontinuation and disposal of the affected lot. For question call 877-308-8289.
Quantity in Commerce 2333 kits
Distribution USA Nationwide Distribution
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 = DCK and Original Applicant = CHOLESTECH CORP.
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