Class 1 Device Recall Alere Triage Profiler SOB Panel PN 97300

• Date Initiated by Firm: May 22, 2012
• Date Posted: July 06, 2012
• Recall Status: Terminated on October 18, 2013
• Recall Number: Z-1930-2012
• Recall Event ID: 61927
• 510(K)Number: K080269
• Product Classification: Fibrinogen and fibrin split products, antigen, antiserum, control - Product Code DAP
• Product: Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
• Code Information: Phase 1: K50708B, W50009B, W50011B, W50012B, W50013B, W50014B, W50016VB, W50021B, W50026B, W50028B, W50030B, W50771B, W50772B, W50773B, W50774B, W50778B, and W50801B. Phase 2: W50015B, W50029B, and W50788B.
• 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: Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
• FDA Determined Cause: Process design
• Action: Phase 1 of the recall included a recall communication being initiated on May 22, 2012 with Alere forwarding a recall letter to all their customers who purchased the Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use of the affected product, and to complete and fax the enclosed verification form within 10 days. Phase 2 of the recall included a recall communication letter being forwarded to customers on 6/11/12. The second letter included additional lots of Triage products that go beyond the lots included in an earlier recall notification letter. The letter informed the customers that the additional lots have significantly decreased precision relative to the package insert which could result in an increased frequency of false positive or false negative results. A third letter dated June 12, 2012 included 3 more lots for the Triage Cardio Profiler Panel PN 97100CP and Alere Triage Profiler SOB Panel PN 97300. The letter informed the customers that the additional lots have an increased frequency of Troponin I results >0.05 ng/mL for samples which are found to be below 0.05 ng/mL upon additional testing. Customers with questions about the information contained in the notifications, were instructed to contact Alere San Diego at (877) 308-8287 or at 9975 Summers Ridge Road, San Diego, CA 92121.
• Quantity in Commerce: 5,013 kits
• Distribution: Nationwide Distribution
• 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 = DAP