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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 Device Recall Cepheid Xpert MRSA/SA Blood Culture see related information
Date Initiated by Firm April 05, 2010
Date Posted July 01, 2010
Recall Status1 Terminated 3 on May 25, 2011
Recall Number Z-1898-2010
Recall Event ID 55670
510(K)Number K082140  
Product Classification system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct sp - 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 CA 94089-1189
For Additional Information Contact
408-541-4191
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NQX and Original Applicant = CEPHEID
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