12.07.2015 Views

Alere Triage ® Voluntary Recall Letter

Alere Triage ® Voluntary Recall Letter

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Please complete this form even if you do not have any involved product andFax Back to Technical Service at Fax Number 858-695-7100.Customer Verification FormUrgent Medical Device <strong>Recall</strong> Notification1. We acknowledge receipt of the <strong>Alere</strong> San Diego, Inc. notice dated, May 22, 2012 for theProduct <strong>Recall</strong> <strong>Alere</strong> <strong>Triage</strong> ® CardioProfiler ® Panel PN 97100CP, <strong>Alere</strong> <strong>Triage</strong> ® CardiacPanel PN 97000HS, <strong>Alere</strong> <strong>Triage</strong> ® Profiler SOB Panel PN 97300, <strong>Alere</strong> <strong>Triage</strong> ® BNP PN98000XR, and <strong>Alere</strong> <strong>Triage</strong> ® D-dimer PN 98100.2. We confirm that all areas where the product could be located have been checked.3. SELECT ALL STATEMENTS THAT APPLYThe following has been verified:We do not have any affected product. If so, indicate zero in the table below.Product was redistributed to another facility.We have the product identified below (please record the product, lot number and quantity)and have disposed of the affected product. (<strong>Alere</strong> will contact you for replacement orcredit. All replacement or credit will be processed using purchase order: ASD512TRG.)We have the product identified below (please record the product, lot number and quantity)and will continue to use the affected product as we have no alternative testing method.Product Name Part Number Lot Number Kit QuantityDATE*:AUTHORIZED SIGNATURE*:PRINT NAME*:TITLE:DEPARTMENT:INSTITUTION*:ADDRESS*:CITY*: STATE*: PHONE*:POSTAL CODE*:COUNTRY*:EMAIL:To satisfy global requirements for regulatory reporting, please complete and return this form within 10 business days of receipt toTechnical Service at Fax Number +1 858-695-7100.<strong>Alere</strong>.com 9975 Summers Ridge Road San Diego, California 92121 USA 4 of 4

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