MRSA/SA Test Recalled Because of Rare False-Negative Results

A test to detect methicillin-resistant Staphylococcus aureus (MRSA) and S aureus (SA) has been recalled by the manufacturer based on an increasing number of complaints about false negatives for MRSA.

The voluntary recall of the Xpert MRSA/SA Blood Culture Assay covers all kits made and distributed from October 21, 2008 through June 21, 2010. The kit is manufactured by Cephid which is based in Sunnyvale, California. The product has been distributed to hospital laboratories worldwide.

Because the test has the rare potential to generate false-negative MRSA results, patients with MRSA infections may receive incorrect treatment or delayed care, according to an alert sent by MedWatch (the US Food and Drug Administration (FDA), the FDA's safety information and adverse event reporting program.

Customers can continue to use the product and report results of MRSA positive/SA positive - however, when customers receive a MRSA negative/SA positive result, the company recommends conducting further antimicrobial susceptibility testing using an FDA-cleared method for an accurate MRSA finding.

Customers with questions about the recall can contact the Cepheid Technical Support at 1-888-838-3222.