If you or a loved one underwent a heart test between June 29, 2011 and March 12, 2012 which included the use of these particular immunoassayies and lot numbers, you/they may have suffered serious health consequences as a result. Contact our office at (731) 423-1888 for information regarding how you may be entitled to compensation.
The FDA has issued a Class 1 RECALL for Roche Diagnostics biochemical tests Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays (lot numbers 163176 and 163177) which were distributed between June 29, 2011 and January 13, 2012. Doctors who used these tests to determine heart damage (as an aid in the diagnosis of a heart attack) may have received a falsely low result and these incorrect results may have caused serious adverse health consequences, including death.
On March 12, 2012, Roche Diagnostics Operations sent an “URGENT MEDICAL DEVICE REMOVAL” letter to all its customers (doctors, clinics, laboratories & hospitals) 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. A Class 1 FDA recall is the most serious type of recall and involve situations in which there is a reasonable probability that use of these products would have caused serious consequences.