Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System - Class I Recall
MedSun: Newsletter #51, August 2010

FDA MedWatch Safety Alert

The firm received increasing numbers of complaints for false negative MRSA results when compared to MRSA positive results received from culture methods. All Cepheid MRSA/SA Blood Culture Assay products have a potential of generating infrequent rates of false negative MRSA results, which could result in incorrect treatment or delay of care for patients with MRSA infection.

Additional Information:

FDA MedWatch Safety Alert. Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System - Class I Recall. July 2, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218038.htm


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