Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part… — Class III medical device recall Z-2431-2015
Terminated recall by Cepheid, reported 2015-08-26, distributed nationwide. Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with a
| Recall number | Z-2431-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cepheid, Sunnyvale, CA, United States |
| Recall initiated | 2015-07-27 |
| Classified | 2015-08-20 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2015-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AW, CA, CH, CL, CO, CR, CY, ES, GT, IT, PA, ZA |
| Lot numbers | 26N121H, 28N134D, 46A202C, 46A202D, 46A202E, 46A202F, 46A202G |
| Model numbers | CT/NGSWAB-50 |
| Expiration dates | 2015-10-20, 2016-11-20 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2431-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.