Roche Diagnostics Operations has initiated a Class 1 recall for its Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays.
With certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50 percent lower than the actual concentration of Troponin I), according to the FDA. These incorrect results may cause serious adverse health consequences, including death, FDA noted.
The affected lot numbers, distributed from June 29, 2011, to Jan. 13, 2012, are 163176 and 163177.
Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays are used to determine heart damage as an aid in the diagnosis of a heart attack.
On March 12, the Indianapolis-based Roche sent an “Urgent Medical Device Removal” letter to customers who received the affected lots of Elecsys Troponin I or Elecsys Troponin I STAT. The letter described the product, problem and actions to be taken.
Customers were instructed to immediately discontinue use of the affected products and discard the affected product from their inventory according to their site’s local regulations.