Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbi...
FDA Device Recall #Z-2431-2015 — Class III — July 27, 2015
Recall Summary
| Recall Number | Z-2431-2015 |
| Classification | Class III — Low risk |
| Date Initiated | July 27, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cepheid |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| Quantity | 729 kits US, 47 kits ROW. |
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.
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.
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.
Lot / 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.
Other Recalls from Cepheid
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0724-2026 | Class II | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Nov 5, 2025 |
| Z-0960-2026 | Class II | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog... | Oct 30, 2025 |
| Z-0959-2026 | Class II | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog... | Oct 30, 2025 |
| Z-0414-2026 | Class II | Xpert SA Nasal Complete Catalog Number: GXSACO... | Aug 6, 2025 |
| Z-2584-2024 | Class II | Cepheid, Sample Collection Device, Part: 900-0370 | Jun 20, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.