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Biosite Triage Cardiac Panel

Biosite Triage Cardiac Panel Side Effects May Lead To Misdiagnosis Lawsuits

Biosite Triage Cardiac Panel | Lawsuits, Lawyers | Side Effects: Misdiagnosis, Failure To Diagnosis Heart Attack, Injury, Death | Faulty Device, False Negative Test

The lawyers / attorneys at our firm are offering free case evaluations to anyone who was injured because of Biosite Incorporated's Triage Cardiac Panel test. One lot of Biosite Triage Cardiac Panel tests was recalled in April 2009 because of the risk they would produce a false negative test result. This defect could cause the test to fail to diagnose a heart attack.

The Biosite Triage Cardiac Panel recall was deemed a Class I recall by the Food & Drug Administration (FDA). A Class I recall is the agency's most serious type of recall. It is only issued when a medical device is likely to cause serious injury or death.

The poor performance of these tests likely endangered many patients and could have led to fatalities. The Biosite Triage Cardiac Panel recall lawyers at our firm are determined to make sure Biosite is held accountable for any injuries and deaths that resulted from this defective product.

If you or someone you know were injured because a recalled Biosite Triage Cardiac Panel test failed to diagnose a heart attack, you may be entitled to compensation. We urge you to contact one of our Biosite Triage Cardiac Panel recall lawyers right away to protect your legal rights.

One-Step Whole Blood Test

Biosite touts the Triage Cardiac Panel as a one-step whole blood test that aids in the diagnosis of acute myocardial infarction (heart attack). According to the company's literature, it provides quantitative measurements of three cardiac markers - myoglobin, Creatine Kinase MB (CK-MB), troponin I - within approximately 15 minutes.

According to Biosite's Web site, the Triage Cardiac Panel is the only available diagnostic test that enables frequent quantitative testing of these three cardiac markers at the point of care. The company claims that studies have demonstrated that frequent monitoring of cardiac markers used in conjunction with rapid care algorithms can improve diagnosis of chest pain in the emergency department and accelerate rule-in or rule-out of heart attacks.

Unfortunately, the Biosite Triage Cardiac Panel may not work as designed. If it does not, a patient could be put in mortal danger. Heart attack patients who are incorrectly diagnosed will likely be sent home from the emergency room without having had appropriate treatment, leading to a high chance of death or disability.

Triage Cardiac Panel Recall

On April 27, 2009,  Biosite sent an urgent notice to its customers making them aware of the recall. Customers were advised to discontinue all use of the Triage Cardiac Panel tests from the affected lot, and discard them. Biosite said it would replace all discarded tests.

The Biosite Triage Cardiac Panel recall was prompted by reports of low recovery of quality control samples containing CK-MB, troponin I and myoglobin. Such low recovery could result in misdiagnosis of a heart attack. 

A root cause for the defect had not yet been determined at the time of the recall. Biosite said in its recall notice that an investigation had been initiated.  Our Biosite Triage Cardiac Panel recall lawyers have represented many victims of defective medical devices. In our experience, such defects are the result of poor quality control on the part of a manufacturer.

The Biosite Triage Cardiac Panel recall involves tests from Lot #W44467B. These recalled tests bear Catalog No. 97000HS.   Only tests from this lot and bearing this catalog number are affected by the recall.

The recalled Biosite Triage Cardiac Panel tests were manufactured on January 23, 2009 and distributed from January 24, 2009 through February 17, 2009.   They were shipped as 25 individually pouched devices per kit box.

Biosite maintains that it has received no reports of injuries or death as a result of the failure of a Triage Cardiac Panel test to diagnose a heart attack. However, the vast majority of defective medical device injuries are never reported. Our Biosite Triage Cardiac Panel recall lawyers fear that many victims of this faulty test are not even aware that it was responsible for their misdiagnosis.

Legal Help for Victims of the Biosite Triage Cardiac Panel Test

If you or someone you love suffered as a result of the failure of a Biosite Triage Cardiac Panel test to diagnose a heart attack, you have valuable legal rights. Please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our Biosite Triage Cardiac Panel recall lawyers at our firm.



 

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