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

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1 URGENT MEDICAL DEVICE RECALL June 11, 2012 Dear Valued 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 Triage BNP PN 98000XR Triage D-dimer PN Attached is a list of the lots which are subject to recall. This set of lots listed pertains to additional Triage product beyond those lots included in an earlier recall notification you may have received. 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.

2 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. Consequently, 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. 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 Summers Ridge Road San Diego, CA U.S.A. Phone: FAX: Sincerely, Robert Di Tullio Vice President, Global Clinical and Regulatory Affairs, Alere Inc. Alere.com 9975 Summers Ridge Road, San Diego, California USA 2 of 6

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4 Fax Back Page 1 of 2 Please complete this form and the attached affected product list, even if you do not have any involved product and Fax Back to Customer Verification Form Urgent Medical Device Recall Notification 1. We acknowledge receipt of the Alere San Diego, Inc. notice dated, June 11, 2012 for the Product Recall Alere Triage CardioProfiler Panel PN 97100CP, Alere Triage Cardiac Panel PN 97000HS, Alere Triage Profiler SOB Panel PN 97300, Alere Triage BNP PN 98000XR, and Alere Triage D-dimer PN 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 attached list of affected product. Product was redistributed to another facility. We have the product identified in the attached list of affected product (please record the quantity) and have disposed of the affected product. (All replacement or credit requests will be processed using purchase order: ASD612TRG.) We have the product identified in the attached list of affected product (please record the quantity) and will continue to use the affected product as we have no alternative testing method. DATE*: AUTHORIZED SIGNATURE*: PRINT NAME*: TITLE: INSTITUTION*: ADDRESS*: DEPARTMENT: CITY*: STATE*: PHONE*: POSTAL CODE*: COUNTRY*: To satisfy global requirements for regulatory reporting, please complete and return this form within 10 business days of receipt to Fax Number *Required Field Alere.com 9975 Summers Ridge Road, San Diego, California USA 4 of 6

5 Fax Back Page 2 of 2 Please complete this list. If you don t have any affected product on hand record the kit quantity as zero (0). Fax Back to List of Affected Product Product Name Part Number Lot Number Kit Quantity Action Requested (choose one if you have the affected product; indicate remaining kit quantity in applicable choice below) Replacement Credit Alere.com 9975 Summers Ridge Road, San Diego, California USA 5 of 6

6 List Of Recalled Lots for Triage CardioProfiler Panel PN 97100CP, Triage Cardiac Panel PN 97000HS, Triage Profiler SOB Panel PN 97300, Triage BNP PN 98000XR and Triage D-dimer PN June 11, 2012 Notification Additional Lots added June 19, 2012 (see highlighted lots) Product Name Lot Number Product Name Lot Number Triage BNP Test K50665B Triage Cardiac Panel W49766B W49855B W50605B W49862B W50627B W49865B W50628B W49887B W50629B W49892B Triage CardioProfiler Panel W49609B W49893B W49610B W49894B W49618B W49900B W49619B W49933B W49626B W49939B W49632B W49953B W49640B W49958B W50737B W49960B W50744B W49961B Triage Profiler SOB Panel W50015B W50252B W50029B W50268B W50788B W50273B Triage D-dimer W50550B W50274B W50290B W50292B W50295B W50297B W50298B W50304B W50355B W50357B W50375B Alere.com 9975 Summers Ridge Road, San Diego, California USA 6 of 6