Incorrect Diagnosis Risk Prompts Elecsys Troponin I Recall

Posted on April 24, 2012

Devices that are used to measure vital statistics in order to allow doctors to make an accurate diagnosis have been recalled due to a risk that the results shown will be incorrect.

The items in question are called Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays.  These products, which were distributed by Roche Diagnostics Operations, are supposed to allow doctors to gauge the amount of heart damage in an individual.  Being able to accurately determine the degree of damage can assist a physician with diagnosing a heart attack.

The problem with these recalled items is that the test results that doctors are looking at might show inappropriately low levels of Troponin I with certain plasma samples.  In fact, it could show levels 50% lower than the actual amount of Troponin I.  This could lead to death or a number of adverse consequences for the patient.

The recall affects lots 163176 and 163177.  Affected customers should have received a letter about the issue after March 12.  That letter was entitled “URGENT MEDICAL DEVICE REMOVAL.”  The product should be discontinued and the instructions of the letter heeded.  Doctors and patients alike are being asked to report to Medwatch should an injurious incident occur.

I tried as a personal injury lawyer in Fresno to break this very technical recall down in a way that’s easy to follow.  The truth is, medical device recalls are some of the most important out there, and we shouldn’t refrain from reporting them just because the jargon is challenging.  I hope as a San Francisco personal injury attorney that the technical nature of this recall doesn’t prevent news outlets from reporting the issue.

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