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U.S. Department of Health and Human Services

Class 3 Device Recall Xpert GBS

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 Class 3 Recall
Xpert GBS
see related information
Date Posted January 12, 2008
Recall Status1 Terminated on April 04, 2008
Recall Number Z-0376-2008
Recall Event ID 45494
Premarket Notification
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/
Manufacturer
Cepheid
904 E Caribbean Dr
Sunnyvale, California 94089-1189
For Additional Information Contact John Bishop, CEO
408-541-4191
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to 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 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 = NJR and Original Applicant = CEPHEID
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