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United States·US-MF-000010979
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 904, Caribbean Drive, Sunnyvale, CA, United States
- Website
- WWW.CEPHEIDINTERNATIONAL.COM
- —
- —
- [email protected]
- Phone
- 18888383222
- PRRC Contact
- Aarthi Raman
- EUDAMED SRN
- US-MF-000010979
- FDA FEI Number
- 3016838963
- DUNS Number
- 956711444
Catalogue (195)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GeneXpert Dx System | GXIV-4 | FDA UDI | Class II | Unknown |
| Xpert C. difficile/Epi | GXCDIFF/EPI-10 | FDA UDI | Class I | Active |
| GeneXpert Dx System | GXXVI-8 | FDA UDI | Class II | Active |
| GeneXpert Dx System | GX-I | FDA UDI | Class II | Active |
| GeneXpert Dx System | GXXVI-4 | FDA UDI | Class II | Unknown |
| Xpert® | XPRSMVP-10 | FDA UDI | Class II | Active |
| SmartCycler Dx System | SC2500N6-1 | FDA UDI | Class I | Active |
| Xpert Carba-R | GXCARBAR-10 | FDA UDI | Class II | Active |
| Xpert MRSA/SA Blood Culture | GXMRSA/SA-BC-10 | FDA UDI | Class II | Active |
| GeneXpert Dx System | GXXVI-8, GXXVI-12 | FDA UDI | Class II | Active |
| Xpert SA Nasal Complete | GXSACOMP-10 | FDA UDI | Class II | Active |
| GeneXpert Dx System | GXIV-2 | FDA UDI | Class II | Active |
| GeneXpert Infinity-80 System | INFINITY 80-64 | FDA UDI | Class II | Unknown |
| GeneXpert Dx System | GXIV-4 | FDA UDI | Class II | Active |
| GeneXpert Dx System | GXIV-1 | FDA UDI | Class II | Active |
| GeneXpert Dx System | GXXVI-16 | FDA UDI | Class II | Unknown |
| Certified Pre-Owned GeneXpert Dx System | GXXVI-4-R | FDA UDI | Class II | Unknown |
| GeneXpert Dx System | GXXVI-8 | FDA UDI | Class II | Unknown |
| GeneXpert Dx System | GXIV-3 | FDA UDI | Class II | Active |
| GeneXpert Infinity-80 System | INFINITY 80-16 | FDA UDI | Class II | Unknown |
| Certified Pre-Owned GeneXpert Dx System | GXIV-2-R | FDA UDI | Class II | Unknown |
| GeneXpert Dx System | GXXVI-4 | FDA UDI | Class II | Active |
| Certified Pre-Owned GeneXpert Dx System | GXII-2-R | FDA UDI | Class II | Unknown |
| Certified Pre-Owned GeneXpert Dx System | GXIV-1-R | FDA UDI | Class II | Unknown |
| Certified Pre-Owned GeneXpert Dx System | GXIV-4-R | FDA UDI | Class II | Unknown |
| 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 | K162456 | FDA 510(k) | Class II | Active |
| Xpert Hemorrhagic Fever | K253653 | FDA 510(k) | N/A | Active |
| Xpert® SA Nasal Complete | K243070 | FDA 510(k) | Class II | Active |
| 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 | K142501 | FDA 510(k) | Class II | Active |
| Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | K222638 | FDA 510(k) | Class I | Active |
| Xpert, Genexpert Dx System | K060540 | FDA 510(k) | Class I | Active |
| Xpert Mtb/Rif Assay | DEN130032 | FDA 510(k) | Class II | Active |
| Smart Gbs And Smartcycle Dx System And Software, Version 1.7b | K062948 | FDA 510(k) | Class I | Active |
| Xpert Mrsa | K070462 | FDA 510(k) | Class II | Active |
| Xpert Xpress CoV-2/Flu/RSV plus | K242071 | FDA 510(k) | Class II | Active |
| Xpert Xpress Strep A | K172126 | FDA 510(k) | Class II | Active |
| Xpert Hemosil Factor Ii & Factor V Assay | K082118 | FDA 510(k) | Class II | Active |
| Xpert Carba-R | K152614 | FDA 510(k) | Class II | Active |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | K221160 | FDA 510(k) | Class II | Active |
| Xpert VanA Assay | K092953 | FDA 510(k) | Class II | Active |
| Xpert Xpress CoV-2/Flu/RSV plus | K250996 | FDA 510(k) | Class II | Active |
| Xpert Carba-R | K160901 | FDA 510(k) | Class II | Active |
| Xpert® FII & FV | K223046 | FDA 510(k) | Class II | Active |
| Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | K203429 | FDA 510(k) | Class I | Active |
| Xpert Ct/Ng | K121710 | FDA 510(k) | Class II | Active |
| Xpert vanA | K243405 | FDA 510(k) | Class II | Active |
| Xpert Flu | K123191 | FDA 510(k) | Class II | Active |
| Xpert Xpress CoV-2/Flu/RSV plus | K250995 | FDA 510(k) | Class II | Active |
| Xpert Xpress MVP; GeneXpert Xpress System | K231381 | FDA 510(k) | Class II | Active |
| Xpert Carba-R | K173263 | FDA 510(k) | Class II | Active |
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FDA Recalls (19)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 5, 2025 | Z-0724-2026 | — | open, classified | Product testing did not meet expected stability criteria. |
| Oct 30, 2025 | Z-0960-2026 | — | open, classified | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. |
| Oct 30, 2025 | Z-0959-2026 | — | open, classified | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. |
| Aug 6, 2025 | Z-0414-2026 | — | open, classified | As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. |
| Jun 20, 2024 | Z-2584-2024 | — | open, classified | 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. |
| Apr 24, 2023 | Z-0215-2024 | — | open, classified | 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. |
| Apr 24, 2023 | Z-0216-2024 | — | open, classified | 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. |
| Oct 9, 2017 | Z-0592-2018 | — | terminated | 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. |
| Sep 15, 2017 | Z-0028-2018 | — | terminated | Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert. |
| Jul 18, 2016 | Z-2548-2016 | — | terminated | Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations. |
| Jul 27, 2015 | Z-2431-2015 | — | terminated | 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. |
| Jul 27, 2015 | Z-2432-2015 | — | terminated | 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. |
| Nov 17, 2011 | Z-0453-2012 | — | terminated | 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. |
| Apr 1, 2011 | Z-2401-2011 | — | terminated | 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. |
| Apr 5, 2010 | Z-1898-2010 | — | terminated | The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients. |
| Feb 19, 2010 | Z-1651-2010 | — | terminated | 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. |
| Feb 19, 2010 | Z-1652-2010 | — | terminated | 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. |
| Sep 5, 2007 | Z-0376-2008 | — | terminated | 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) |
| Jul 22, 2005 | Z-1378-05 | — | terminated | A problem in the software has the potential to be associated with the incorrect reporting of sample results. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Cepheid AB SOLNA Stockholm · SE FEI 3009613136