Voluntary Recall Notice

URGENT MEDICAL DEVICE RECALL 

May 22, 2012 

Dear Valued Triage Customer: 

Alere San Diego, Inc. is initiating a voluntary recall of certain lots of the following products: 

Triage ®  CardioProfiler ®  Panel PN 97100CP   

Triage  ®  Cardiac Panel PN 97000HS 

Triage ®  Profiler SOB™ Panel PN 97300 

Triage 

Triage 

® 

®  

BNP PN 98000XR 

D‐dimer PN 98100  

Our shipping records indicate you have received one or more of the affected products and lots which are  subject to recall.  Attached is a listing of the recalled products for your reference.   (Please note that your  facility may also receive a customized letter listing only the affected product and lot numbers shipped to  your location.) 

These lots 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 may not be detected by  your Quality Control testing.   There have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results. If you question any previously 

  reported results, we recommend you consult with your resident clinical expert or physician in the  setting where the test was performed.

Please refer to the following pages of this letter and follow instructions for Triage recall decision  pathway and disposition of product. 

As a result of this situation, we expect to have a limited inventory to supply the product demand to all  customers. We are significantly increasing production to accommodate our customers’ needs;  however, the duration of supply disruptions is not known.  

Alere sincerely apologizes for the difficulty this situation may cause your facility.  We value our  relationship with you and apologize for this unanticipated burden.  An Alere representative will work  closely with you to determine and manage product availability for your facility.

CUSTOMER REQUIRED ACTION 

 Immediately discontinue all use of the recalled products and lots and switch to an  alternative method for measuring these analytes if no unaffected lots are available. 

 If an alternate method is not available and you cannot obtain any unaffected lots, we  strongly recommend the following:  o Perform a validation of the affected lot(s) that you have available until you  are able to implement an alternative method.  o Since the affected devices have significantly decreased precision than  claimed, we strongly recommend testing samples in duplicate.  o It is unknown when replacement lots will be available, we strongly  recommend implementing alternative methods for measuring these analytes. 

 If you have a supply of unaffected Triage product, you do not need to take any action.   

 Immediately inform clinicians of this recall at the testing site(s) that have utilized these  recalled products.   

 Complete and FAX the enclosed Verification Form within 10 days to confirm your  receipt of this notice even if you do not have any remaining product from these lots.  

Destroy all remaining affected product if you have an alternative method. You will be  contacted to arrange for replacement of products, if available, or credit. 

 Please share this information with your laboratory staff and retain this notification as  part of your laboratory Quality System documentation. 

 If you have forwarded the product listed above to another laboratory, please provide a  copy of this letter to them. 

 Please refer to the attached Triage Recall Decision Pathway for further clarity in making  a determination of your institution’s actions. 

Should you have any questions about the information contained in this notification, please contact: 

Alere San Diego, Inc. 

9975 Summers Ridge Road 

San Diego, CA  92121 

U.S.A. 

Phone: 877 308 8287 

FAX:    858 695 7100 

Sincerely, 

Robert Di Tullio 

Vice President, Global Clinical and Regulatory Affairs, Alere Inc.       

Alere.com 9975 Summers Ridge Road San Diego, California 92121 USA 2 of 4

Alere.com 9975 Summers Ridge Road San Diego, California 92121 USA 3 of 4

Please complete this form even if you do not have any involved product and

Fax Back to Technical Service at Fax Number 858-695-7100.

Customer Verification Form

Urgent Medical Device Recall Notification

1. We acknowledge receipt of the Alere San Diego, Inc. notice dated, May 22, 2012 for the

Product Recall Alere Triage

®

CardioProfiler

®

Panel PN 97100CP, Alere Triage

®

Panel PN 97000HS, Alere Triage

98000XR, and Alere Triage

®

®

Profiler SOB™ Panel PN 97300, Alere Triage

D-dimer PN 98100.

®

Cardiac

BNP PN

2. We confirm that all areas where the product could be located have been checked.

3. SELECT ALL STATEMENTS THAT APPLY

The 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. (Alere will contact you for replacement or credit. 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 Quantity

DATE*:

AUTHORIZED SIGNATURE*:

PRINT NAME*:

TITLE: DEPARTMENT:

INSTITUTION*:

ADDRESS*:

CITY*:

POSTAL CODE*:

STATE*:

COUNTRY*:

PHONE*:

EMAIL:

To satisfy global requirements for regulatory reporting, please complete and return this form within 10 business days of receipt to

Technical Service at Fax Number +1 858-695-7100.

Alere.com 9975 Summers Ridge Road San Diego, California 92121 USA 4 of 4