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U.S. Department of Health and Human Services

Class 3 Device Recall Xpert GBS

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  Class 3 Device Recall Xpert GBS see related information
Date Initiated by Firm September 05, 2007
Date Posted January 12, 2008
Recall Status1 Terminated 3 on April 04, 2008
Recall Number Z-0376-2008
Recall Event ID 45494
510(K)Number K060540  
Product Classification Nucleic Acid Amplification Assay System, (Group b streptococcus, direct specimen test) - Product Code NJR
Product Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089
Code Information Lot Number : 1402
Recalling Firm/
904 E Caribbean Dr
Sunnyvale CA 94089-1189
For Additional Information Contact John Bishop, CEO
Manufacturer Reason
for Recall
Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file)
FDA Determined
Cause 2
Release of Material/Component prior to receiving test results
Action Consignees were sent a Correction and Removal letter on 09/04/2007, notifying them that there was a labeling error with some of the cartridges labels indicating Xpert EV instead of Xpert GBS on the cartridge label. They are asked to discontinue using it immediately and return to Cepheid.
Quantity in Commerce 105
Distribution Worldwide Distribution
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 = NJR and Original Applicant = CEPHEID