Class I Recall of Cepheid’s Xpert MRSA/SA Blood Culture Assay products for use with GeneXpert Dx System

As reported on fda.gov, “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.”

“On July 1, 2010, the company issued a press release and sent its customers a revised Corrective Action Notice letter instructing them not to report the MRSA negative result when a MRSA negative/SA positive result is generated on the Cepheid MRSA/SA Blood Culture Assay. Instead, customers were instructed to conduct further antimicrobial susceptibility testing to determine the MRSA result. The MRSA positive/SA positive results generated on the Cepheid MRSA/SA Blood Culture Assay can still be reported. The new instructions will be incorporated in future product labeling. “

The FDA goes on to note that Class I recalls are the most serious type of recall, and that if the products are used, there is a reasonable probability that they will cause serious adverse health consequences, or death.

More information, including model and lot numbers, can be found on the FDA’s website at: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm218002.htm.