FDA Device recall Z-2431-2015
Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50
- FDA Device
- Class III
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class III recall of Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50 by Cepheid, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2431-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-27 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cepheid |
| Distribution | US |
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
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.
Identifiers
| code_info | Part number: CT/NGSWAB-50: Lot numbers: 46A202C, 46A202D, 46A202E, 46A202F, 46A202G, Flock swab expires end of July 20…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Cepheid
- Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Device · Class II · 2025-12-24 · Cepheid - Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Device · Class II · 2025-12-24 · Cepheid - Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10
FDA Device · Class II · 2025-12-03 · Cepheid - Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit
FDA Device · Class II · 2025-11-05 · Cepheid - Cepheid, Sample Collection Device, Part: 900-0370
FDA Device · Class II · 2024-08-21 · Cepheid
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2431-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.