Device 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.
Z-2432-2015
Product summary
- Firm
- Cepheid
- Event
- Event 71841
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1800 kits US, 31 ROW
- Official record key
device-enforcement:Z-2432-2015
Official wording
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.
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.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.