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U.S. Department of Health and Human Services

Class 1 Device Recall Cepheid Xpert MRSA/SA Blood Culture

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 Class 1 Recall
Cepheid Xpert MRSA/SA Blood Culture
see related information
Date Posted July 01, 2010
Recall Status1 Terminated on May 25, 2011
Recall Number Z-1898-2010
Recall Event ID 55670
Premarket Notification
510(K) Number
K082140 
Product Classification System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen - Product Code NQX
Product 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.
Code Information 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)
Recalling Firm/
Manufacturer
Cepheid
904 E Caribbean Dr
Sunnyvale, California 94089-1189
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Quantity in Commerce 5,510 units
Distribution Worldwide distribution: USA and Europe, Taiwan, and Australia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NQX and Original Applicant = CEPHEID
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