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Class 3 Device Recall Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit GXCT/NGSWAB50 |
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Date Initiated by Firm |
July 27, 2015 |
Date Posted |
August 20, 2015 |
Recall Status1 |
Terminated 3 on September 28, 2015 |
Recall Number |
Z-2431-2015 |
Recall Event ID |
71841 |
510(K)Number |
K121710
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Product Classification |
Dna-reagents, neisseria - Product Code LSL
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Product |
Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50;
Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay. |
Code Information |
Part number: CT/NGSWAB-50: Lot numbers: 46A202C, 46A202D, 46A202E, 46A202F, 46A202G, Flock swab expires end of July 2015. Kit expires October 2015. Lot numbers 26N121H, and 28N134D.- Cleaning swabs expire end of June 2016. Kits expires November 2016. |
Recalling Firm/ Manufacturer |
Cepheid 904 E Caribbean Dr Sunnyvale CA 94089-1189
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For Additional Information Contact |
Jason Affourtit 888-838-3222
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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.
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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 |
729 kits US, 47 kits 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
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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.
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510(K) Database |
510(K)s with Product Code = LSL and Original Applicant = CEPHEID
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