SUNNYVALE, Calif., July 1 Cepheid is initiating a recall of all lots of Xpert® MRSA/SA BC (blood culture) product. 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.
Advertisement
Hospitals or laboratories 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.
Advertisement
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 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 US 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.
Customers with questions may contact the company at 888-838-3222.
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 1-800-FDA-1088, by Fax at 1-800-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.
CONTACTS: For Customer Inquiries: For Media Inquiries: Rick Fletcher Jared Tipton Vice President, Regulatory Cepheid Corporate Communications Compliance & Quality Systems 408-400-8377 408-542-8566 [email protected] [email protected]
SOURCE Cepheid
