According to the US FDA’s Medwatch, certain Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays, used to determine heart damage as an aid in the diagnosis of a heart attack, are faulty. These are manufactured by the Swiss pharma company Roche diagnostics.
On March 12, 2012, Roche Diagnostics Operations sent an “URGENT MEDICAL DEVICE REMOVAL” letter to all its 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products.
For more details, see the FDA Medwatch