ABBOTT PARK, Ill., May 25 /PRNewswire-FirstCall/ -- Abbott today announced that it has initiated a voluntary, nationwide recall of its ARCHITECT(R) STAT Troponin-I diagnostic test. The product was distributed to clinical laboratories in the United States and internationally and is used to aid in the diagnosis of injury to heart muscle and/or heart attack.
Normally levels of Troponin, a protein found in muscle, are very low; even slight elevations can indicate some degree of damage to the heart. Abbott initiated this voluntary recall of the product (List #2K41, all lots) after receiving a small number of complaints related to inconsistent or invalid test results at very low levels of Troponin-I (i.e., less than 0.1ng/mL). A negative test result at these levels could indicate that a person has not had heart muscle injury or heart attack, when in fact they may have for some patients. At higher levels most commonly used for making clinical decisions and evaluating patient results (i.e., 0.1ng/mL and 0.3 ng/mL), the product continues to work as described in the product labeling.
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. Abbott has reported the action to the U.S. Food and Drug Administration. 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.
Any adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program by mail to MedWatch at 5600 Fishers Lane, Rockville, MD 20852-9787, by fax to 1-800-FDA-0178 or online at http://www.fda.gov/medwatch/report.htm.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/.
