MRSA Tests Recalled

The MRSA test, <"">Cepheid Xpert MRSA/SA Blood Culture Assay, which is used with the GeneXpert Dx System, has been recalled in a Class I recall, the U.S. Food and Drug Administration (FDA) just announced. A Class I recall is the agency’s most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.

The recall was initiated on April 5, 2010 and includes the following. All kits manufactured and distributed from October 21, 2008 through June 21, 2010 are affected by this recall:

• Model Number GXMRSA/SA-BC-10 with Lot Numbers 00902, 00903,00904, 01001, 01101, 01102, 01301, 01302, 02001, 02002.

• Model Number GXMRSA/SA-BC-CE-10 with Lot Numbers 01001, 01101, 01301.

This test is used to detect Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA directly from a patient’s positive blood culture that was found to be Gram Positive Cocci in Clusters (GPCC) or Gram Positive Cocci in singles (GPC) by a Gram stain.

The recalling firm—Cepheid located at 904 E. Caribbean Drive / Sunnyvale / California / 94089-1189—is receiving an increasing numbers of complaints for false negative MRSA results when compared to MRSA positive results received from cultures. Because of this, sll Cepheid MRSA/SA Blood Culture Assay products have the potential to generate false negative MRSA results, which could lead to incorrect treatment or delay of care for patients who are actually sickened with MRSA infection. Customers may contact Cepheid Technical Support toll-free at 1-888-838-3222.

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. 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 and new instructions will be incorporated in future product labeling.

This entry was posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.