FDA Device

Elecsys Troponin T; catalog number 2017644

Hazard

Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.

What You Should Do

Remedy

An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL.

Products

Elecsys Troponin T; catalog number 2017644
Brand
Roche Diagnostics Corp.
UPC
All lots.