Abbott announced that it initiated a voluntary, nationwide recall of its Architect Stat Troponin-I diagnostic test. The product, which was distributed to clinical laboratories in the US and internationally, is used to aid in the diagnosis of injury to heart muscle and/or heart attack.
Abbott initiated the recall after receiving complaints related to inconsistent or invalid test results at very low levels of Troponin-I (i.e., less than 0.1ng/mL).
No patient injuries have been reported, the company said, adding that laboratories may continue to use the product with updated directions for use, which Abbott is distributing.
The company said it has identified the root cause of the problem and is working on correcting the issue. Abbott also reported the action to the FDA.
