Heads, MRSA. Tails, possibly MRSA.
Dear Valued Customer:
Based on the recall announced July 1, 2010, 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 results should be interpreted as MRSA indeterminate/Staphylococcus aureus positive, antimicrobial susceptibility testing pending. Further testing should be performed using an FDA-cleared, phenotypic antimicrobial susceptibility testing method on isolated colonies recovered from the blood culture bottle. 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.
The following statement will be added to the Interpretation of Results section of the package insert for "MRSA Negative/SA Positive" results:
The results 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.
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.