Cepheid Xpert MRSA Test Kit Recall: Kits May Give False Negatives

Blood tests by Cepheid that are designed to check for the presence of methicillin-resistant Staphylococcus aureus (MRSA) and staph infections are being recalled because they have been found to give false negatives, telling doctors that patients are free from infection when they are not. 

The Cepheid Xpert MRSA/SA test recall was announced July 1 by the FDA and the manufacturer after several complaints were received. The FDA has determined that the defective blood culture tests’ problems constitute a Class 1 recall, the most serious form of medical device recall. A class 1 recall classification means that the FDA believes the product defect is likely to cause serious injury or death.

All lots of the Cepheid Xpert MRSA/SA Blood Culture Assay were recalled, with model numbers GXMRSA/SA-BC-10 and GXMRSA/SA-BCE-10. The test kits are designed for use with the GeneXpert Dx System, and were distributed between October 21, 2008 and June 21, 2010.

The tests have been found to potentially give infrequent false negatives, which could tell doctors that an infected patient’s blood is clean, delaying life-saving treatment and potentially continuing the spread of community or hospital acquired infections to other patients or members of the public.

In a press release, Cepheid gave instructions on how to better interpret the test results, and noted that positive readings could still be trusted. According to the company, at least some of the false negatives are due to new types of MRSA strains emerging that the blood test was designed to handle. However, the new MRSA strains do not account for all of the false negative reports.

MRSA infections, also known as “superbug” infections, have been steadily growing in the U.S. over the last decade. According to the U.S. Centers for Disease Control and Prevention (CDC), there are more than 2 million hospital infections acquired each year, resulting in about 90,000 deaths annually. Another 1.5 million long term care and nursing home infections occur every year. MRSA, which resists treatment by many antibiotics, has accounted for more than 60 percent of hospital staph infections in recent years.

In recent years, there has been an increasing number of hospital infection lawsuits filed throughout the United States, as experts believe that most of these potentially life-threatening infections can be prevented if steps are taken by the hospital and staff.