Drug maker, Roche, is recalling two of its Elecsys Troponin Immunoassays, the U.S. Food & Drug Administration (FDA) just announced. The recall has been deemed a Class I by the agency, its most severe and involving a situation in which there exists a reasonable probability that the use of, or exposure to, the recalled, violative product—in this case, the Roche Elecsys Troponin Assays—will cause serious adverse health consequences or death.
The Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays are used to determine heart damage as an aid when diagnosing a heart attack.
With certain types of plasma samples, doctors may receive a falsely low result that can be up to a maximum of 50% lower than the actual concentration of Troponin I. These incorrect results may cause serious adverse health consequences, which include death.
Specifically, Roche is recalling its Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays with the following lot numbers: 163176, 163177. The recalled Assays were distributed June 29, 2011 through January 13, 2012 and have been recalled by Roche Diagnostics Operations, Inc.: 9115 Hague Road, Indianapolis, Indiana, 46256-1025.
Roche Diagnostics Operations sent an “Urgent Medical Device Removal” letter to all of its customers known to have received the affected lots of Elecsys Troponin I or Elecsys Troponin I STAT. The letter described the product, the problem, and the actions to be taken. Customers were instructed to:
- Immediately discontinue use of the recalled Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays and discard these recalled products from inventory, in compliance with local regulations.
- Contact other sites if the facility distributed the recalled Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays; ensure that the Roche Diagnostics Operations’ letter reaches those sites.
- Complete and return the form attached the “Urgent Medical Device Removal” letter and fax the form, toll-free, to 1.888.912.8457.
- Maintain Roche’s “Urgent Medical Device Removal” letter for future reference.
- Contact Roche Diagnostics Technical Support at its 24-hour, toll-free number with any questions about the information contained in the letter. Roche Diagnostics Technical Support can be reached 24 hours a day, seven days a week, toll-free, at 1.800.428.2336.
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. Information on the Program can be accessed at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm