Recall of Cardiac Diagnostic Tests

Recall of Cardiac Diagnostic Tests

As a New York medical malpractice attorney I appreciate the risks faced by patients when medical caregivers do not abide by reasonable standards of care.

Beyond the conduct of medical staff members, it is also important that the tools and devices used in hospitals and clinics (and often placed inside patient bodies) be made safely.

That isn’t always the case.

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Whether it is from dangerous medicine, like the Novartis recall of popular medicines like Excedrin, or for medical devices, like defective implants or test kits, patients can suffer serious harm even when receiving top-notch care if the products used are not safe.

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Food and Drug Administration Recall

For example, last week the Food and Drug Administration (FDA) issued a Class 1 recall on several cardiovascular diagnostic test kits because of a potentially fatal error that increases the rate of false positive and false negative results.

A Class 1 recall affects products with a reasonable risk of serious adverse effects or death.

It is the most serious recall issued by the FDA.

The test kits which do not provide proper precision include Triage CardioProfiler Panel, Cardiac Panel, Profiler SOB Panel, BNP, and D-dimer tests.

These products feature a meter and various test devices and are used to help diagnose cardiac diseases and conditions, including heart failure and myocardial infarction as well as aid in assessing patients for pulmonary embolism.

Certain recalled lots have increased frequency of false positive Troponin I results.

Other affected test kits are used to identify 11 drugs, including cocaine, acetaminophen, and marijuana.

The FDA warned that these defects cannot be detected in quality control testing.

This recall affects 98,100 units in 49 different lots of test kit products:

  • Distributed between September 8, 2011 and June 5, 2012; and
  • Manufactured between June 12, 2011 and April 8, 2010

According to the manufacturer, about 70% of US hospitals use the diagnostic tests.

They also are available in more than 50 international markets.

The manufacturer, Alere, issued an urgent recall notice on May 22, 2012 following reports of problems due to erroneous results from these diagnostic tests.

This was a voluntary recall by the company.

A follow up notice was issued on June 11, 2012 adding additional products to the recall, as did another follow up on June 12.

These updates nearly doubled the number of products recalled under the original notice.

Alere is still in talks with the FDA to determine the final requirements for the release of new products after September.


Alere requests the discontinuance or discarding of any of these affected devices.

The FDA is recommending that healthcare professionals and patients 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.

In addition, as with all harm caused by negligence or defective products, the civil law provides avenues to ensure proper accountability and redress for the individual patients harmed.

If you or a family member has been affected by an unsafe medical device in our area, contact a New York medical malpractice lawyer as soon as possible to discuss potential legal assistance.

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About Anthony T. DiPietro

Founder Anthony T. DiPietro, Esq. is a compassionate and skilled trial attorney who has completely dedicated the past 23 years of his career to litigating medical malpractice and sexual abuse cases against major corporate institutions including hospitals, medical clinics, schools, and other wrongdoers.

Mr. DiPietro has also obtained some of New York State’s highest verdicts and settlements, and has been selected to New York State Super Lawyers® each year, for the past 10 years in a row.

In 2022, Mr. DiPietro was selected as one of America’s Top 100 High-Stakes Litigators for the landmark cases he’s won on behalf of survivors of sexual exploitation and abuse.

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Here, at The DiPietro Law Firm, we’re committed to helping victims of sexual abuse and assault find the justice they deserve.

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