Call For A Free Consultation

866-822-8237

Our Results

Cardiac Diagnostic Tests Recalled

WASHINGTON -- The FDA has issued a Class I recall on several lots of cardiovascular diagnostic tests because of a potentially fatal sensitivity error that increases the rate of false positive and false negative results.

The affected Triage CardioProfiler Panel, Cardiac Panel, Profiler SOB Panel, BNP, and D-dimer tests do not provide the precision described in the package insert, the agency wrote in a statement.

The false results are unpredictable within lots and cannot be distinguished through quality control sampling, the agency noted.

The recall affects 49 lots of products, which were manufactured from June 12, 2011 to April 8, 2012 and distributed from Sept. 8, 2011 to June 5, 2012. An estimated 98,100 units are affected by the recall.

The devices are indicated as a rapid diagnostic test system for conditions including heart failure and MI and are used to aid in assessing pulmonary embolism.

Manufacturer Alere issued an urgent recall notice on May 22, 2012, following reports of inappropriate clinical management because of the erroneous results.

A follow-up notice issued June 11, 2012 added additional product lots to the recall, and a third letter, issued one day later, added three more lots. The third notice also notified customers of increased frequency of false positive troponin I results in the newly-listed units.

Class I recalls affect products with a reasonable risk of serious adverse events or death with use.

Source: Cole Petrochko, Associate Staff Writer, MedPage Today-Published: July 11, 2012

No Comments

Leave a comment
Comment Information

Local Affiliation With Accomplished Trial Lawyers

Our partners are available as local counsel to out-of-state law firms in Michigan medical malpractice and personal injury litigation.Inquiries and referrals welcome.

Email Us For a Response

Reach Out To Us Today

Bold labels are required.

Contact Information
disclaimer.

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.

close

Privacy Policy

Goethel Engelhardt, PLLC
3049 Miller Road
Ann Arbor, MI 48103

Toll Free: 866-822-8237
Phone: 734-545-8421
Fax: 734-769-7935
Ann Arbor Law Office Map

google plus
map
Review Us