Z-2431-2015Class III

Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The...

Name: Z-2431-2015 Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The...
Creator: Cepheid
Published: 2015-07-27
License: https://open.fda.gov/license/

Cepheid / initiated 2015-07-27 / Terminated

FDA source

Cepheid began a recall of Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen... on 2015-07-27. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2431-2015
Classification: Class III
Status: Terminated
Initiated: 2015-07-27
Posted: 2015-08-20
Terminated: 2015-09-28
Recalling firm: Cepheid
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.
Product code: LSL Dna-Reagents, Neisseria
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.
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2431-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2431-2015	Class III	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2432-2015	Class III	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20

Product code LSL

K121710Class IIXpert Ct/ngCepheid / cleared 2012-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)