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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiac Marker Test

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  Class 2 Device Recall Cardiac Marker Test see related information
Date Initiated by Firm May 02, 2014
Date Posted June 06, 2014
Recall Status1 Terminated 3 on February 27, 2015
Recall Number Z-1727-2014
Recall Event ID 68230
510(K)Number K042890  
Product Classification Fibrin split products - Product Code GHH
Product Alere Triage¿ D-Dimer Test
PN 98100, Lot W53884B.
The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
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The Alere Triage¿ D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Code Information PN 98100, Lot W53884B.
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-805-2000 Ext. 3015
Manufacturer Reason
for Recall		 Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.
FDA Determined
Cause 2		 Under Investigation by firm
Action Alere sent an Urgent Medical Device Recall letter dated May 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to stop using all product from the affected lot, lot W53884B, and to discard any unused product. The customers were also instructed to complete and return the verification form indicating any credit or replacement product requested. They were also instructed to contact their primary consignees and advise them of the notice. Should you have any questions about the information contained in this notification, please call (877) 308-8287. and /or email:Triage.Support@alere.com
Quantity in Commerce 373 kits
Distribution Nationwide Distribution only.
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 = GHH and Original Applicant = BIOSITE INCORPORATED
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