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U.S. Department of Health and Human Services

Medical Devices

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Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System


Recall Class:  Class I

Date Recall Initiated:  April 5, 2010

Product:  Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System

 

Model Numbers

Lot Numbers

GXMRSA/SA-BC-10

 

00902, 00903,00904,

01001, 01101, 01102, 01301,

01302, 02001, 02002

GXMRSA/SA-BC-CE-10

 

01001, 01101, 01301

All kits manufactured and distributed from October 21, 2008 through June 21, 2010 are affected by this recall.

Use: This test is used to detect methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA directly from patient positive blood culture determined to be Gram Positive Cocci in Clusters (GPCC) or Gram Positive Cocci in singles (GPC) by Gram stain.

Recalling Firm:

Cepheid

904 E. Caribbean Drive

Sunnyvale, California  94089-1189

Reason for Recall:

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.

Public Contact:  Customers may contact the Cepheid Technical Support at 1-888-838-3222 for any questions regarding this recall.

FDA District:  San Francisco

FDA Comments:

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. 

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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