A Medical Device Daily

Abbott Laboratories (Abbott Park, Illinois) reported that it has initiated a voluntary, nationwide recall of its Architect STAT Troponin-I diagnostic test. The product was distributed to clinical laboratories in the U.S. 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 after receiving what it said were a "small number of complaints" related to inconsistent or invalid test results at very low levels of Troponin-I (i.e., less than 0.1 ng/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., 0.1 ng/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 said it has identified the root cause and is working on correcting the issue. It has reported the action to the FDA.

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