Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.
- Company
- Cepheid
- Recall Initiated
- April 5, 2010
- Posted
- July 1, 2010
- Terminated
- May 25, 2011
- Recall Number
- Z-1898-2010
- Quantity
- 5,510 units
- Firm Location
- Sunnyvale, CA
Reason for Recall
The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.
Distribution
Worldwide distribution: USA and Europe, Taiwan, and Australia.
Lot / Code Info
Product codes GXMRSA/SA-BC-10 (lot numbers 00601, 00602, 00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101, 01102, 01301, 01302) and GXMRSA/SA-BC-CE-10 (lot numbers 01001, 01101, 01301)
Root Cause
Nonconforming Material/Component
Action Taken
The firm, Cepheid, issued a technical bulletin to customers on April 5, 2010 and an updated to the April 5 bulletin dated April 9, 2010 instructing them to perform a reflexive repeat test on any blood culture results initially determined as having SA. If further information on this please contact your Cepheid Sales Representative 1-888-336-2743 or www.CEPHEID.COM.