WEDNESDAY, July 7 (HealthDay News) -- In response to an increasing number of complaints of false-negative results, Cepheid has alerted customers to a recall of all lots of Xpert methicillin-resistant Staphylococcus aureus/Staphylococcus aureus (MRSA/SA) blood culture assay products for use with the GeneXpert Dx System.
According to Cepheid, the products' potential to generate infrequent rates of false-negative MRSA results could lead to incorrect treatment or delay of care for patients who are actually infected with MRSA. The recall is a corrective action, which means practitioners can continue to use the product and are not required to return it to the company.
According to Cepheid, when an MRSA negative/SA positive result is obtained, the result should be considered "MRSA indeterminate/SA positive, antimicrobial susceptibility testing pending," with more testing performed with a U.S. Food and Drug Administration-cleared, phenotypic antimicrobial susceptibility method on isolated colonies from the blood culture bottle. However, MRSA positive/SA positive results generated on the assay can still be reported as positive results. The Xpert MRSA/SA blood culture assay product was distributed to hospital laboratories worldwide. The FDA has labeled this recall as Class I, with one adverse event reported to the agency.
"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," according to a statement released by Cepheid. "The failure investigation has not fully determined the remaining causes of the false-negative MRSA results."
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