Cepheid
Medical device manufacturer in Sunnyvale, CA.
59510(k) clearances
0PMA approvals
18recalls
Device types
- NQX System, Nucleic Acid Amplification Test… 10
- OCC Respiratory Virus Panel Nucleic Acid Assay… 8
- NJR Nucleic Acid Amplification Assay System… 5
- QOF Multi-Target Respiratory Specimen Nucleic… 4
- PQA Vaginitis And Bacterial Vaginosis Nucleic… 3
- POC System, Nucleic Acid Amplification Test… 3
- QQX Respiratory Specimen Nucleic Acid… 2
- NPR Test, Factor Ii G20210a Mutations, Genomic… 2
- PGX Groups A, C And G Beta-Hemolytic… 2
- OUY Trichomonas Vaginalis Nucleic Acid… 2
- PCH Gastrointestinal Pathogen Panel Multiplex… 2
- LSL Dna-Reagents, Neisseria 2
- OQW 2009 H1n1 Influenza Virus (Swine Origin)… 2
- NIJ System, Test, Genotypic Detection… 2
- PEU System, Nucleic Acid-Based, Mycobacterium… 1
- PMY System, Nucleic Acid Amplification Test… 1
- QEP Nucleic Acid Detection System For Non-Viral… 1
- QVR Multiplex Nucleic Acid Detection System For… 1
- OMN C. Difficile Nucleic Acid Amplification… 1
- NPQ Test, Factor V Leiden Mutations, Genomic… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | 08/07/2026SE |
| K261867 | Xpert Carba-RPOC · Special | 07/02/2026SE |
| K253653 | Xpert Hemorrhagic Fever · Traditional | 02/20/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | 01/16/2026SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | 02/28/2025SE |
| K250218 | Xpert® FII & FVNPR · Special | 02/21/2025SE |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track | 01/15/2025SE |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track | 01/10/2025SE |
| K243625 | Xpert MRSA/SA SSTINQX · Special | 12/18/2024SE |
| K243405 | Xpert vanANIJ · Special | 11/21/2024SE |
| K243070 | Xpert® SA Nasal CompleteNQX · Special | 10/25/2024SE |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress SystemPQA · Dual Track | 10/19/2023SE |
| K230440 | Xpert® Xpress CoV-2 plusQQX · Traditional | 10/13/2023SE |
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsNJR · Traditional | 09/27/2023SE |
| K231481 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Traditional | 08/17/2023SE |
| K223046 | Xpert® FII & FVNPR · Special | 02/15/2023SE |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA · Special | 06/07/2022SE |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemNJR · Traditional | 05/09/2022SE |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA · Traditional | 02/09/2022SE |
| K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert…OYX · Traditional | 09/27/2019SE |
| K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80…QEP · Traditional | 05/23/2019SE |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…NQX · Special | 04/25/2019SE |
| K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…OCC · Traditional | 08/15/2018SE |
| K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…OCC · Dual Track | 07/24/2018SE |
| K173398 | Xpert Xpress Strep APGX · Dual Track | 04/26/2018SE |
| K173840 | Xpert CT/NGLSL · Traditional | 03/16/2018SE |
| K173263 | Xpert Carba-RPOC · Traditional | 01/09/2018SE |
| K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…OCC · Dual Track | 12/19/2017SE |
| K172126 | Xpert Xpress Strep APGX · Traditional | 09/25/2017SE |
| K162456 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…OCC · Traditional | 02/13/2017SE |
| K162331 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…OCC · Traditional | 02/09/2017SE |
| K162444 | Xpert MRSA NxGNQX · Traditional | 11/23/2016SE |
| K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…OUY · Traditional | 08/29/2016SE |
| K160901 | Xpert Carba-RPOC · Traditional | 06/29/2016SE |
| K152614 | Xpert Carba-RPMY · Traditional | 03/07/2016SE |
| K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…OCC · Dual Track | 12/03/2015SE |
| K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…OUY · Traditional | 10/16/2015SE |
| K143302 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s…PEU · Traditional | 02/12/2015SE |
| K142501 | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert…PCH · Traditional | 11/26/2014SE |
| K142045 | Xpert Flu/Rsv XC AssayOCC · Traditional | 11/22/2014SE |
| K130894 | Xpert Mrsa/Sa Blood Culture Assay; Genexpert DX Systems (Gx-I, Gx-Ii, Gx-Iv, Gx-Xvi)…NQX · Traditional | 06/20/2013SE |
| K121710 | Xpert Ct/NgLSL · Traditional | 12/27/2012SE |
| K123191 | Xpert FluOCC · Traditional | 12/21/2012SE |
| K121539 | Xpert GBS LB Genexpert DX Systems (Gx-I, Gx-Iv) Genexpert DX Systems (Gx-Xvi) Genexpert…NJR · Traditional | 11/02/2012SE |
| K120911 | Xpert Flu Genexpert DX Systems (Gx-I, Gx-Iv)OQW · Traditional | 05/18/2012SE |
| K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software…OQW · Traditional | 04/21/2011SE |
| K110203 | Xpert C. Difficle/Epi AssayOMN · Traditional | 04/07/2011SE |
| K101879 | Xpert Mrsa/Sa BC (Blood Culture) Assay Model GXMRSA/SA-BC-10NQX · Special | 07/28/2010SE |
| K100822 | Xpert Mrsa/Sa Nasal AssayNQX · Traditional | 06/01/2010SE |
| K092953 | Xpert VanA AssayNIJ · Traditional | 12/17/2009SE |
| K082118 | Xpert Hemosil Factor II & Factor V AssayNPQ · Traditional | 09/18/2009SE |
| K091109 | Xpert C. DifficileLLH · Traditional | 07/09/2009SE |
| K082140 | Xpert Mrsa/Sa Blood Culture AssayNQX · Traditional | 09/29/2008SE |
| K080837 | Xpert Mrsa/Sa Ssti AssayNQX · Traditional | 09/24/2008SE |
| K070462 | Xpert MrsaNQX · Traditional | 04/17/2007SE |
| K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7BNJR · Traditional | 12/08/2006SE |
| K060540 | Xpert, Genexpert DX SystemNJR · Traditional | 07/25/2006SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0724-2026 Class II | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.Product testing did not meet expected stability criteria. | 11/05/2025Open, Classified |
| Z-0960-2026 Class II | Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may… | 10/30/2025Open, Classified |
| Z-0959-2026 Class II | Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may… | 10/30/2025Open, Classified |
| Z-0414-2026 Class II | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA…As a result of Post-Market half-time stability testing, false negative test result was observed for a… | 08/06/2025Open, Classified |
| Z-2584-2024 Class II | Cepheid, Sample Collection Device, Part: 900-0370Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes… | 06/20/2024Open, Classified |
| Z-0216-2024 Class II | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in… | 04/24/2023Open, Classified |
| Z-0215-2024 Class II | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Onlypipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in… | 04/24/2023Open, Classified |
| Z-0592-2018 Class II | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075…Cepheid has received reports that some of our customers have experienced a higher number of temperature… | 10/09/2017Terminated |
| Z-0028-2018 Class II | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse…Customers have reported a higher than expected number of invalid test results when using the recalled… | 09/15/2017Terminated |
| Z-2548-2016 Class II | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay…Internal investigation found the certain lots of MRSA kits have the potential for performance issues at… | 07/18/2016Terminated |
| Z-2432-2015 Class III | Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology:…Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with… | 07/27/2015Terminated |
| Z-2431-2015 Class III | Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50…Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with… | 07/27/2015Terminated |
| Z-0453-2012 | Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers:…Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid… | 11/17/2011Terminated |
| Z-2401-2011 | Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for…A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results… | 04/01/2011Terminated |
| Z-1898-2010 | Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System…The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill… | 04/05/2010Terminated |
| Z-1652-2010 | Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA.…Firm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test… | 02/19/2010Terminated |
| Z-1651-2010 | Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA.…Firm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test… | 02/19/2010Terminated |
| Z-0376-2008 | Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for…Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information… | 09/05/2007Terminated |