Roche Diagnostics Operations announced a Class I recall of Elecsys Troponin I or Elecsys Troponin I STAT Immunoassays, Lot numbers 163176, 163177. The affected lots were distributed from June 29, 2011 through January 13, 2012. 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.
These products were recalled because, with certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). These incorrect results may cause serious adverse health consequences, including death.
Customers should immediately discontinue use of the affected products, discard the affected product from their inventory according to their site’s local regulations, and contact other sites if their facility distributed the affected products.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
See the FDA Recall