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Recall of Abbott Troponin-I Immunoassay

Posted on April 29, 2008

Abbott Laboratories is conducting a voluntary recall of all lots of the company's ARCHITECT STAT Troponin-I test because of a small number of complaints of inconsistent or invalid results at very low levels of troponin. Some of the invalid results were falsely elevated and some were falsely decreased.

Patient treatment could be affected in either case. A falsely elevated result could lead to needless treatment of a non-existent heart attack, and a falsely decreased result could indicate that the patient had not experienced a heart attack when in fact an MI had taken place.

Laboratories can continue to use this product, but should follow the updated instructions that Abbott has distributed. The company is advising laboratories to be cautious when reporting results at or near the lower limit of detection. They should also advise physicians ordering the tests about the possibility of inaccurate results at those levels, and to re-test in certain circumstances. For more information, laboratories can call Abbott Customer Support at 1-877-422-2688.

Additional Information:

FDA MedWatch Safety Alert. Abbott Laboratories Architect Stat Troponin-1 Immunoassay. June 8, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Architect

Abbott Press Release. Abbott Diagnostics Issues Voluntary Nationwide Recall of ARCHITECT® STAT Troponin-I Test. May 25, 2007.
http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0470.htm

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