Manufacturer Recalls Troponin I Assay

The FDA and Abbott Laboratories have announced a recall of the company’s ARCHITECT STAT Troponin-I immunoassay, used to measure troponin I levels for the diagnosis of cardiac injury or MI.

The recall is categorized as Class 1 — meaning that the product defect could cause serious health problems — and comes after some labs reported falsely elevated or decreased results at very low levels of troponin I (<0.1 ng/mL).

“Laboratories are advised to be cautious when reporting results at or near the lower limit of detection and to advise physicians ordering the tests about the possibility of inaccurate results at those levels,” the FDA warns.