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CEPHEID

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
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
18888383222
PRRC Contact
Aarthi Raman
EUDAMED SRN
US-MF-000010979
FDA FEI Number
3016838963
DUNS Number
956711444

Catalogue (195)

Page 4 of 4
DeviceModel / ReferenceRegistriesClassStatus
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System K190771
FDA 510(k)
Class IIActive
Xpert® Xpress CoV-2 plus K230440
FDA 510(k)
Class IIActive
Xpert CT/NG K173840
FDA 510(k)
Class IIActive
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) K151226
FDA 510(k)
Class IIActive
Xpert HCV; GeneXpert Xpress System DEN240016
FDA 510(k)
Class IIActive
Xpert Ev, Model Gxev-100n-10; Genexpert Dx System, Models P/N 900-0144, 900-0145, 900-0146, 900-0065 DEN070004
FDA 510(k)
Class IIActive
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 K190441
FDA 510(k)
Class IIActive
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 K161619
FDA 510(k)
Class IIActive
Xpert® FII & FV K250218
FDA 510(k)
Class IIActive
Xpert GI Panel K251721
FDA 510(k)
Class IIActive
Xpert Flu Genexpert Dx Systems (gx-I, Gx-Iv) K120911
FDA 510(k)
Class IIActive
Xpert Flu, Genexpert Dx Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 And 4.0 K103766
FDA 510(k)
Class IIActive
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System K212213
FDA 510(k)
Class IIActive
Xpert Mrsa/Sa Ssti Assay K080837
FDA 510(k)
Class IIActive
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV K180218
FDA 510(k)
Class IIActive
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 K162331
FDA 510(k)
Class IIActive
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems K190076
FDA 510(k)
Class IIActive
Xpert Mrsa/Sa Nasal Assay K100822
FDA 510(k)
Class IIActive
Xpert Mrsa/Sa Blood Culture Assay K082140
FDA 510(k)
Class IIActive
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 K181289
FDA 510(k)
Class IIActive
Xpert® Xpress CoV-2 plus (XPRS-COV2-10) K242109
FDA 510(k)
Class IIActive
Xpert Xpress CoV-2/Flu/RSV plus K231481
FDA 510(k)
Class IIActive
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV K171552
FDA 510(k)
Class IIActive
Xpert MRSA NxG K162444
FDA 510(k)
Class IIActive
Xpert Xpress Strep A K173398
FDA 510(k)
Class IIActive
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 K143302
FDA 510(k)
Class IIActive
Xpert Mrsa/Sa Blood Culture Assay; Genexpert Dx Systems (gx-I, Gx-Ii, Gx-Iv, Gx-Xvi); Genexpert Infinity-48 System; Gene K130894
FDA 510(k)
Class IIActive
Xpert C. difficile/Epi K243730
FDA 510(k)
Class IIActive
Xpert C. Difficle/Epi Assay K110203
FDA 510(k)
Class IActive
Xpert Mrsa/Sa Bc (blood Culture) Assay Model Gxmrsa/Sa-Bc-10 K101879
FDA 510(k)
Class IIActive
Xpert MRSA/SA SSTI K243625
FDA 510(k)
Class IIActive
Xpert C. Difficile K091109
FDA 510(k)
Class IActive
Xpert Gbs Lb Genexpert Dx Systems (gx-I, Gx-Iv) Genexpert Dx Systems (gx-Xvi) Genexpert Infinity-48 System (900-Xxxx) K121539
FDA 510(k)
Class IActive
Xpert Flu/Rsv Xc Assay K142045
FDA 510(k)
Class IIActive
GeneXpert GeneXpert II (GX-II)
EUDAMEDFDA UDI
Class AActive
Xpert® GXGBS-100N-10
EUDAMEDFDA UDI
IVD GeneralActive
GeneXpert® GX-INFINITY 80
EUDAMEDFDA UDI
Class AActive
GeneXpert® GeneXpert IV (GX-IV)
EUDAMEDFDA UDI
Class AActive
GeneXpert® GeneXpert XVI (GX-XVI)
EUDAMEDFDA UDI
Class AActive
Xpert® SWAB/A-50
EUDAMEDFDA UDI
Class AActive
Xpert® URINE/A-50
EUDAMEDFDA UDI
Class AActive
Xpert® SWAB/F-100
EUDAMEDFDA UDI
Class AActive
GeneXpert® GeneXpert IV (GX-IV)-RS
EUDAMEDFDA UDI
Class AActive
Xpert® SWAB/G-50
EUDAMEDFDA UDI
Class AActive
Xpert® GXFFPE-LYSIS-CE-10
EUDAMEDFDA 510(k)FDA UDI
Class AActive

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Authorities

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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.

DateRecall No.ClassStatusReason
Nov 5, 2025Z-0724-2026—open, classified

Product testing did not meet expected stability criteria.

Oct 30, 2025Z-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, 2025Z-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, 2025Z-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, 2024Z-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, 2023Z-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, 2023Z-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, 2017Z-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, 2017Z-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, 2016Z-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, 2015Z-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, 2015Z-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, 2011Z-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, 2011Z-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, 2010Z-1898-2010—terminated

The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.

Feb 19, 2010Z-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, 2010Z-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, 2007Z-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, 2005Z-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