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U.S. Department of Health and Human Services

Class 3 Device Recall Cepheid Xpert MRSA/S Blood Culture

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  Class 3 Device Recall Cepheid Xpert MRSA/S Blood Culture see related information
Date Initiated by Firm November 17, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on January 09, 2012
Recall Number Z-0453-2012
Recall Event ID 60481
510(K)Number K082140  K101879  
Product Classification in vitro diagnostic MRSA - Product Code NQX
Product Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;
Code Information Lots affected: 2803 and 3001
Recalling Firm/
Manufacturer		 Cepheid
904 E Caribbean Dr
Sunnyvale CA 94089-1189
For Additional Information Contact Judith A Howard
408-541-4191
Manufacturer Reason
for Recall		 Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 11/17/11, Cepheid issued letters via mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.
Quantity in Commerce 1289
Distribution Product was released for distribution in US.
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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