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.
FDA Recall Z-1898-2010 · Posted 2010-07-01
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Recalling FirmCepheid
Recall StatusTerminated
Product CodeNQX
Date Initiated2010-04-05
Date Terminated2011-05-25
Product Quantity5,510 units
Reason for Recall
The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA and Europe, Taiwan, and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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