The U.S. Food and Drug Administration (FDA) listed Roche Diagnostics today on the agency’s Class 1 Medical Devices Recall List. The products in question are Roche Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays distributed between June 29, 2011 and January 13, 2012.
The recall cites that certain types of plasma samples used with the assays may produce falsely low results up to a maximum of 50% lower than the actual concentration of Troponin I. Incorrect results such as these “may cause serious adverse health consequences, including death.”
Roche has issued letters to customers known to have received the products in question with reporting and disposal instructions.
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. Troponin biomarker tests in general are frequently utilized to assess cardiac injury such as a heart attack, and to distinguish chest pain that may be due to other causes.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, by telephone, or by FAX.
Specific lot numbers for recalled products are available at the FDA Medical Device List of Recalls page.