Cepheid: Medical Device Recall in 2015 - (Recall #: Z-2431-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: July 27, 2015

Date Posted: August 26, 2015

Recall Number: Z-2431-2015

Event ID: 71841

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.

Status: Terminated

Product Quantity: 729 kits US, 47 kits ROW.

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated