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U.S. Department of Health and Human Services

Safety

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Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result

AUDIENCE: Cardiology, Laboratory

ISSUE: 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. The affected lot numbers are 163176 and 163177.

BACKGROUND: 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.  

RECOMMENDATION: 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 to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[04/24/2012 – Recall Notice - FDA]