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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Nationwide Voluntary Recall Issued for CARDIAC ReaderT System

Contact:
Joel Reuter (Corporate Communications)
(317) 521-7431
Lori LeRoy (Media Relations)
(317) 521-7159

FOR IMMEDIATE RELEASE -- Indianapolis, IN -- December 8, 2004 -- Roche Diagnostics today announced a recall for the CARDIAC Reader™ system due to the potential that the system could start the measuring process before the user applies the sample. As a result, there is a potential for falsely decreased or false negative Troponin T results and falsely decreased Myoglobin results. These tests are used as part of the diagnostic process for myocardial infarction (heart attack).

To date, Roche Diagnostics has not received any complaints in the U.S. No injuries or false results have been reported from this event.

This recall action does not affect Roche's Elecsys® Troponin T STAT reagent pack, Elecsys Myoglobin STAT reagent pack, or TROPT Sensitive Rapid assay strips.

After notifying the US Food and Drug Administration recently, Roche Diagnostics initiated the recall by contacting the less than 100 facilities in the U.S. that are currently using the CARDIAC Reader System. Roche is instructing all of these facilities to return their units to Roche Diagnostics. The company is working with its customers to determine the best alternative to continue providing Troponin T and Myoglobin results using alternative Roche Diagnostics products, or other means.

Roche Diagnostics voluntarily initiated this recall action after reviewing practice patterns in the U.S. and is working directly with the U.S. Food and Drug Administration to ensure that all appropriate parties are notified. Laboratory customers who need to review the field correction action notice can do so by logging into their customer website at www.mylabonline.com.

Roche Diagnostics is committed to the CARDIAC Reader platform and intends to upgrade the system for reintroduction into the U.S. market as soon as possible. Roche Diagnostics will continue its focus and development of cardiac biomarkers for the healthcare community.

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