Alere Triage Diagnostic Tests (Multiple Tests) Recalled due to Risk of Significantly Decreased Precision

The US FDA informs Laboratory, Cardiology, Pulmonology and Risk Manager healthcare personnel that Alere Triage Diagnostic Tests are recalled because there is a potential for significantly decreased precision. This can lead to inappropriate clinical management of patients and serious adverse events including death.

Background of Alere Triage Diagnostic Tests

Triage, by Alere San Diego, Inc, is a rapid diagnostic test system that consists of a meter and various test devices for the diagnosis of various diseases and health conditions including myocardial infarction and heart failure. Moreover, it is used in patients’ assessment for pulmonary embolism.

FDA Alert on Alere Triage Diagnostic Tests

FDA’s reason for the recall is that there is the risk of significantly decreased precision from specific lots which can lead to false positive or negative results. Additional testing from specific lots showed that they have an increased frequency of Troponin I results >0.05 ng/mL for samples found below 0.05 ng/mL. The erroneous results might lead to inappropriate clinical management of patients causing serious adverse events including death.

The affected lots are:

• 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.

The manufacture dates range from 06/12/2011 to 04/08/2012 and the distribution dates from 09/08/2011 to 06/05/2012. In total, 98,100 test kits may be defective.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Alere Triage Diagnostic Tests

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

Contacting the FDA to report cases with Alere Triage Diagnostic Tests

In case of detection of adverse events or side effects related to the use of Alere Triage Diagnostic Tests, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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