Cepheid
Sunnyvale, CA, US
CEPHEID appears in FDA device records in Sunnyvale, CA. FDA records list 62 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 19 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 62FDA records hold 62 510(k) clearances for Cepheid between 2006 and 2026. The busiest year on record is 2025, with 6. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 4 |
| 2018 | 5 |
| 2019 | 3 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 4 |
| 2025 | 6 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261362 | Xpert Hemorrhagic Fever | QVR | Substantially Equivalent | |
| K261867 | Xpert Carba-R | POC | Substantially Equivalent | |
| K253653 | Xpert Hemorrhagic Fever | Substantially Equivalent | ||
| K251721 | Xpert GI Panel | PCH | Substantially Equivalent | |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | Substantially Equivalent | |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | Substantially Equivalent | |
| K243730 | Xpert C. difficile/Epi | OZN | Substantially Equivalent | |
| K250218 | Xpert® FII & FV | NPR | Substantially Equivalent | |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | QQX | Substantially Equivalent | |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | Substantially Equivalent | |
| K243625 | Xpert MRSA/SA SSTI | NQX | Substantially Equivalent | |
| K243405 | Xpert vanA | NIJ | Substantially Equivalent | |
| K243070 | Xpert® SA Nasal Complete | NQX | Substantially Equivalent | |
| DEN240016 | Xpert HCV; GeneXpert Xpress System | SBP | Unknown | |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | PQA | Substantially Equivalent | |
| K230440 | Xpert® Xpress CoV-2 plus | QQX | Substantially Equivalent | |
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | NJR | Substantially Equivalent | |
| K231481 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | Substantially Equivalent | |
| K223046 | Xpert® FII & FV | NPR | Substantially Equivalent | |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | PQA | Substantially Equivalent | |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | NJR | Substantially Equivalent | |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | PQA | Substantially Equivalent | |
| K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems | OYX | Substantially Equivalent | |
| K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit | QEP | Substantially Equivalent | |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | NQX | Substantially Equivalent | |
| K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System | OCC | Substantially Equivalent | |
| K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | OCC | Substantially Equivalent | |
| K173398 | Xpert Xpress Strep A | PGX | Substantially Equivalent | |
| K173840 | Xpert CT/NG | LSL | Substantially Equivalent | |
| K173263 | Xpert Carba-R | POC | Substantially Equivalent | |
| K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | OCC | Substantially Equivalent | |
| K172126 | Xpert Xpress Strep A | PGX | Substantially Equivalent | |
| K162456 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | OCC | Substantially Equivalent | |
| K162331 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | OCC | Substantially Equivalent | |
| K162444 | Xpert MRSA NxG | NQX | Substantially Equivalent | |
| K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems | OUY | Substantially Equivalent | |
| K160901 | Xpert Carba-R | POC | Substantially Equivalent | |
| K152614 | Xpert Carba-R | PMY | Substantially Equivalent | |
| K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) | OCC | Substantially Equivalent | |
| K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit | OUY | Substantially Equivalent | |
| K143302 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 | PEU | Substantially Equivalent | |
| K142501 | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | PCH | Substantially Equivalent | |
| K142045 | XPERT FLU/RSV XC ASSAY | OCC | Substantially Equivalent | |
| DEN130032 | XPERT MTB/RIF ASSAY | PEU | Unknown | |
| K130894 | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE | NQX | Substantially Equivalent | |
| K121710 | XPERT CT/NG | LSL | Substantially Equivalent | |
| K123191 | XPERT FLU | OCC | Substantially Equivalent | |
| K121539 | XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) | NJR | Substantially Equivalent | |
| K120911 | XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) | OQW | Substantially Equivalent | |
| K103766 | XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 | OQW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004530258 | 3004530258 | CEPHEID | 904 CARIBBEAN DRIVE, Sunnyvale, CA 94089 US | 2026 | and 27 more, listed in full below |
| 3017994049 | 3017994049 | CEPHEID | 44509 Pacific Commons Boulevard, Fremont, CA 94538 US | 2026 | No device listings on this registration |
| 3009613136 | 3009613136 | CEPHEID AB | Rontgenvagen 5, SOLNA Stockholm SE-171 54 SE | 2026 | and 4 more, listed in full below |
| 3016838963 | 3016838963 | Cepheid | 121 N Guild Ave, Lodi, CA 95240 US | 2026 | and 25 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
- NIAAssay, Direct, Nucleic Acid Amplification, Influenza Virus
- OAIAssay, Enterovirus Nucleic Acid
- OYXBcr/Abl1 Monitoring Test
- OMNC. Difficile Nucleic Acid Amplification Test Assay
- OZNC. Difficile Toxin Gene Amplification Assay
- JJHClinical Sample Concentrator
- JSMCulture Media, Non-Propagating Transport
- MKZDna Probe, Nucleic Acid Amplification, Chlamydia
- QDCDna-Based Test For Minimal Residual Disease For Hematologic Malignancies
- LSLDna-Reagents, Neisseria
- PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- NSUInstrumentation For Clinical Multiplex Test Systems
- QBDMicrobial Nucleic Acid Storage And Stabilization Device
- OHQMulti-Analyte Controls Unassayed
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- QVRMultiplex Nucleic Acid Detection System For Biothreat Agents
- NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- LLHReagents, Clostridium Difficile Toxin
- QTPReagents, Monkeypox Virus Nucleic Acid.
- OOIReal Time Nucleic Acid Amplification System
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- SBPSimple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
- OWDSomatic Gene Mutation Detection System
- POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
- PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
- NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- PEUSystem, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
- NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
- NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
- MMWSystem, Test, Tumor Marker, Monitoring, Bladder
- NPRTest, Factor Ii G20210a Mutations, Genomic Dna Pcr
- NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr
- OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System
- PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0724-2026 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Product testing did not meet expected stability criteria. | Class II | Open, Classified | |
| Z-0960-2026 | Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. | Class II | Open, Classified | |
| Z-0959-2026 | Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. | Class II | Open, Classified | |
| Z-0414-2026 | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique | As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. | Class II | Open, Classified | |
| Z-2584-2024 | Cepheid, Sample Collection Device, Part: 900-0370 | Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results. | Class II | Open, Classified | |
| Z-0216-2024 | 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 "invalid" results or no result test results. | Class II | Open, Classified | |
| Z-0215-2024 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. | Class II | Open, Classified | |
| Z-0592-2018 | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test. | Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims. | Class II | Terminated | |
| Z-0028-2018 | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis. | Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert. | Class II | Terminated | |
| Z-2548-2016 | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization | Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations. | Class II | Terminated | |
| Z-2432-2015 | Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay. | 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. | Class III | Terminated | |
| Z-2431-2015 | 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. | 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. | Class III | Terminated | |
| Z-0453-2012 | Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001; | Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product. | Terminated | ||
| Z-2401-2011 | Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48 | A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession. | Terminated | ||
| Z-1898-2010 | Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing. | The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients. | Terminated | ||
| Z-1652-2010 | Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA. | Firm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test Results due to "Invalid" test reports from our system when they have been conducting their own internal validation studies using banked frozen repository specimens. | Terminated | ||
| Z-1651-2010 | Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA. | Firm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test Results due to "Invalid" test reports from our system when they have been conducting their own internal validation studies using banked frozen repository specimens. | Terminated | ||
| Z-0376-2008 | Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089 | Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file) | Terminated | ||
| Z-1378-05 | SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler | A problem in the software has the potential to be associated with the incorrect reporting of sample results. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Cepheid edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain