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/ Manufacturer |
Cepheid 904 E Caribbean Dr Sunnyvale CA 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 |
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
|
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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
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