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Recall Observatory FDA recall evidence

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

July 27, 2015

Class III

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

    reason.no_named_rule · v1.0.0

    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.