May 29, 2007 — Abbott announced Friday, May 25, that it has initiated a voluntary, nationwide recall of its ARCHITECT STAT Troponin-I diagnostic test. The product was distributed to clinical laboratories both in the U.S. and abroad, and is used to aid in the diagnosis of injury to heart muscle and/or heart attack.
No patient injuries have been reported. Laboratories may continue to use the product with the updated directions for use, which Abbott is distributing to clinical labs.
The additional instructions provide that: (a) for laboratories or physicians using 0.1 ng/mL or less than 0.1 ng/mL as the cut-off, samples should be retested and/or serial negative blood draws over time should be evaluated before patients are classified as negative for a heart attack; (b) recent negative results less than 0.1 ng/mL should also be re-evaluated and the ordering physicians should be notified; (c) laboratory reports of negative patient results less than 0.1 ng/mL should contain the cautionary language contained in (a) and (b) above.
Abbott previously issued a product correction notice to customers explaining the issue and advising them to evaluate and adjust the reference ranges used in their laboratory when running this test.
Abbott has identified the root cause and is working on correcting the issue — the company has reported the action to the FDA. No other ARCHITECT assays or Abbott instruments are affected.
A Troponin-I test is usually ordered, along with other cardiac tests, in the hospital to determine if a patient has had a heart attack or other injury to heart muscle. The test, conducted using a sample of the patient's blood, aids in the diagnosis of myocardial injury or infarction. The results of Troponin-I tests should be used in conjunction with other diagnostic information including other cardiac markers, ECG, clinical observations and symptoms. As with any diagnostic test, Abbott recommends in its product labeling that results from the ARCHITECT STAT Troponin-I test be interpreted in conjunction with other clinical and laboratory findings.
Clinical laboratory customers with questions may contact the company at 1-877-4ABBOTT.
For more information visit www.fda.gov/medwatch/report.htm and www.abbott.com.