Recall Z-2431-2015 ยท LSL Dna-Reagents, Neisseria
Cepheid
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 Xp
| Date | Aug 20, 2015 (initiated Jul 27, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Incorrect or no expiration date |
| Action | Notification letters dated July 28 and 29th to all affected customers via Federal Express.. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121710 | XPERT CT/NG Cepheid, Dec 27, 2012 |