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U.S. Department of Health and Human Services

Class 3 Device Recall Xpert CT/NG Urine Specimen Collection Kit GXCT/NGSWAB50

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  Class 3 Device Recall Xpert CT/NG Urine Specimen Collection Kit GXCT/NGSWAB50 see related information
Date Initiated by Firm July 27, 2015
Date Posted August 20, 2015
Recall Status1 Terminated 3 on September 28, 2015
Recall Number Z-2432-2015
Recall Event ID 71841
510(K)Number K121710  
Product Classification Dna-reagents, neisseria - Product Code LSL
Product Xpert CT/NG Urine Specimen Collection Kit
Part number GXCT/NGURINE-50;

Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.
Code Information Part number: GXCT/NGURINE-50; Lot numbers: 23E104B, 23E104C, 26N128C, 26N1281, 29N142A, 29N142B, 29N142C, 29N142D, 29N142E, 29N142F, and 29N142G All with transfer pipette expiring end of May, June or July 2016. Collection kits expires in August, September, October of November 2016.
Recalling Firm/
Manufacturer		 Cepheid
904 E Caribbean Dr
Sunnyvale CA 94089-1189
For Additional Information Contact Jason Affourtit
888-838-3222
Manufacturer Reason
for Recall		 Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Notification letters dated July 28 and 29th to all affected customers via Federal Express..
Quantity in Commerce 1800 kits US, 31 ROW
Distribution Worldwide distribution. US nationwide, including North Mariana Islands, Aruba, Canada, Chile, Colombia, Costa Rica, Cyprus, Guam, Guatemala, Italy, Malawi, Micronesia Federated States, Panama, San Marino, South Africa, Spain, Switzerland, and Zimbabwe.
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 = LSL and Original Applicant = CEPHEID
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