Cepheid
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 50
- Inspections
- 7
- Compliance Actions
- 1
Known Names
cepheid, cepheid®
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0724-2026 | Class II | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | November 5, 2025 |
| Z-0960-2026 | Class II | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 | October 30, 2025 |
| Z-0959-2026 | Class II | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 | October 30, 2025 |
| Z-0414-2026 | Class II | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal | August 6, 2025 |
| Z-2584-2024 | Class II | Cepheid, Sample Collection Device, Part: 900-0370 | June 20, 2024 |
| Z-0216-2024 | Class II | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, | April 24, 2023 |
| Z-0215-2024 | Class II | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | April 24, 2023 |
| Z-0592-2018 | Class II | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/ | October 9, 2017 |
| Z-0028-2018 | Class II | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polym | September 15, 2017 |
| Z-2548-2016 | Class II | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed i | July 18, 2016 |
| Z-2432-2015 | Class III | Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG | July 27, 2015 |
| Z-2431-2015 | Class III | Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiolo | July 27, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253653 | Xpert Hemorrhagic Fever | February 20, 2026 |
| K251721 | Xpert GI Panel | January 16, 2026 |
| K250218 | Xpert® FII & FV | February 21, 2025 |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | January 10, 2025 |
| DEN240016 | Xpert HCV; GeneXpert Xpress System | June 27, 2024 |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | October 19, 2023 |
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | September 27, 2023 |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | June 7, 2022 |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | May 9, 2022 |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | February 9, 2022 |
| K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems | September 27, 2019 |
| K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXper | May 23, 2019 |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity- | April 25, 2019 |
| K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, Gen | August 15, 2018 |
| K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, | July 24, 2018 |
| K173398 | Xpert Xpress Strep A | April 26, 2018 |
| K173840 | Xpert CT/NG | March 16, 2018 |
| K173263 | Xpert Carba-R | January 9, 2018 |
| K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, Gen | December 19, 2017 |
| K172126 | Xpert Xpress Strep A | September 25, 2017 |