Cepheid is recalling all lots of Xpert MRSA/SA BC (blood culture) product. This test is used to detect methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA directly from patient positive blood culture determined to be Gram Positive Cocci in Clusters (GPCC) or Gram Positive Cocci in singles (GPC) by Gram stain.
The recall is a corrective action, which does not require return of product to the manufacturer. Customers may continue to use the product; however, when a MRSA negative/SA positive result is obtained, the result should be interpreted as "MRSA indeterminate/SA positive, antimicrobial susceptibility testing pending."
Further testing should be performed using a FDA-cleared, phenotypic antimicrobial susceptibility testing method on isolated colonies recovered from the blood culture bottle, as instructed in the Corrective Action Notice dated July 1, 2010.MRSA positive/SA positive results can still be reported as such. The new instructions will be incorporated in the product labeling. The Xpert MRSA/SA BC product produces false-negative MRSA results, which could potentially contribute to incorrect treatment of an MRSA infection.
Hospitals that have purchased the Xpert MRSA/SA BC product subject to this corrective action may continue to use all product within their inventory subject to the new instructions stated in the Corrective Action Notice as of July 1, 2010. Customers should contact Cepheid Technical Support at (888) 838-3222 if they have questions regarding this corrective action.
This corrective action is a Class I recall, which includes the following product catalog numbers:
-- Xpert MRSA/SA BC (GXMRSA/SA-BC-10)
-- Xpert MRSA/SA BC CE-IVD (GXMRSA/SA-BC-CE-10)
Cepheid voluntarily issued this corrective action after learning of rare, false-negative MRSA results from the testing of blood culture samples. The Food and Drug Administration (FDA) has been apprised of this action.
Although the product appears to continue to meet performance claims as outlined in the current product labeling, an ongoing failure investigation has identified the emergence of novel MRSA strain types as one of the causes of false-negative MRSA results. The failure investigation has not fully determined the remaining causes of the false-negative MRSA results. To date, one adverse event has been reported to the FDA through the MDR process.
The Xpert MRSA/SA BC product was distributed to hospital laboratories worldwide. For U.S. customers it can be identified by Cepheid labeling: Xpert MRSA/SA BC, Catalog Number GXMRSA/SA-BC-10. For European customers, the product can be identified by GXMRSA/SA-BC-CE-10.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at (800) FDA-1088, by fax at (800) FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852 9787, or on the MedWatch website at www.fda.gov/medwatch.
All kits manufactured and distributed from October 21, 2008 through June 21, 2010 are affected by this recall.