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U.S. Department of Health and Human Services

Medical Devices

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Alere, Triage (Multiple Tests)

Recall Class: Class I

Date Recall Initiated: May 22, 2012

Products:

  • Triage CardioProfiler Panel PN 97100CP
  • Triage Cardiac Panel PN 97000HS
  • Triage Profiler SOB Panel PN 97300
  • Triage BNP PN 98000XR
  • Triage D-dimer PN 98100

Model/catalog/lot numbers:
Identified 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 false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. There have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results. To locate identified lot numbers, see Firm Recall Letter under Additional Links below.

Range of manufacturing and distribution dates: Manufactured from 06/12/2011 to 04/08/2012. Distributed from 09/08/2011 to 06/05/2012.

Use: Alere Triage is a rapid diagnostic test system comprised of a meter and various test devices that aid in the diagnosis of diseases and health conditions including heart failure and myocardial infarction as well as aid in assessing patients for pulmonary embolism.

Recalling Firm:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121

Reason for Recall:

On May 22, 2012, the firm sent an Urgent Medical Device 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. Customers were instructed to discontinue use of the affected product, and to complete and fax a verification form back to the firm within 10 days.

On June 11, 2012, the firm sent a second letter to customers with additional lots of Triage products to be recalled. 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.

This product may cause serious adverse health consequences, including death. 98,100 test kits have the potential to be defective.

Public Contact: Alere San Diego, Inc. 877-308-8287

FDA District: Los Angeles

FDA Comments:

The firm requests customers to immediately discontinue all use and discard any remaining product and to use unaffected lots or alternative methods for measuring these analytes. In addition, the firm requests customers to share this recall information with laboratory staff, and for customers who have forwarded product listed in this recall to other laboratories to notify those laboratories immediately.

There may not currently be sufficient unaffected product to supply the product demand for all laboratories. The duration of supply disruptions are not known.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links: