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Cepheid Recalls One of Its MRSA Tests

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Cepheid said after the market closed Thursday that it has initiated a recall of all lots of its Xpert MRSA/SA blood culture product because it produces false-negative MRSA (methicillin-resistant Staphylococcus aureus) results, which could potentially contribute to incorrect treatment of an MRSA infection.

The firm said the recall is a corrective action, which does not require a return of the product. It said, however, that when customers obtain an MRSA negative/SA positive result, that result should be interpreted as "MRSA indeterminate/SA positive, antimicrobial susceptibility testing pending." In addition, Cepheid instructed that further testing should be performed using a FDA-cleared, phenotypic antimicrobial susceptibility testing method on isolated colonies recovered from the blood culture bottle.

The test detects the presence of methicillin-resistant Staphylococcus aureus or S. aureus in gram positive blood culture bottles in less than one hour. It was cleared by the US Food and Drug Administration for marketing in October 2008 and is distributed to hospital labs worldwide.

The catalog numbers for the products affected by the recall include Xpert MRSA/SA BC (GXMRSA/SA-BC-10) for the US products and Xpert MRSA/SA BC CE-IVD (GXMRSA/SA-BC-CE-10) for the European product.

Cepheid said that ongoing investigation has identified the emergence of novel MRSA strain types as one of the causes of false-negative MRSA results, but it has not fully determined the remaining causes of the false-negative MRSA results. The firm also noted that, to date, one adverse event has been reported to the FDA.