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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 2 of 4

Device	Model / Reference	Registries	Class	Status
Xpert Check	XPERTCHECK-US-5	FDA UDI	Class I	Active
Xpert MRSA	GXMRSA-120	FDA UDI	Class II	Active
GeneXpert®	GXHCV-10	FDA UDI	Class II	Active
GeneXpert Dx System	GXIV-1	FDA UDI	Class II	Unknown
SmartCycler Dx System	SC2500N17-1	FDA UDI	Class I	Active
GeneXpert Dx System	GXII-2	FDA UDI	Class II	Active
GeneXpert Infinity-80 System	INFINITY 48-40	FDA UDI	Class II	Active
SmartCycler Dx System	SC2500N14-1	FDA UDI	Class I	Active
GeneXpert®	XPRS-COV2-10	FDA UDI	Class II	Active
GeneXpert Infinity-80 System	INFINITY 80-72	FDA UDI	Class II	Unknown
Certified Pre-Owned GeneXpert Dx System	GXXVI-12-R	FDA UDI	Class II	Unknown
Certified Pre-Owned GeneXpert Dx System	GXXVI-8-R	FDA UDI	Class II	Unknown
SmartCycler Dx System	SC2500N16-1	FDA UDI	Class I	Active
Xpert®	GXGBSLBXC	FDA UDI	Class I	Active
SmartCycler Dx System	SC2500N4-1	FDA UDI	Class I	Active
Xpert Norovirus	GXNOV-10	FDA UDI	Class II	Active
SmartCycler Dx System	SC2500N18-1	FDA UDI	Class I	Active
GeneXpert Infinity-80 System	INFINITY 48-24	FDA UDI	Class II	Active
GeneXpert®	INFINITY48-16	FDA UDI	Class II	Active
Xpert®	GXGBSLBXC	FDA UDI	Class I	Active
GeneXpert Dx System	GXXVI-12	FDA UDI	Class II	Unknown
GeneXpert Dx System	GXIV-4	FDA UDI	Class II	Active
SmartCycler Dx System	SC2500N2-1	FDA UDI	Class I	Active
Xpert C. difficile	GXCDIFFICILE-120	FDA UDI	Class I	Active
GeneXpert Dx System	GX-I	FDA UDI	Class II	Active
GeneXpert Infinity-80 System	INFINITY 48-48	FDA UDI	Class II	Active
GeneXpert Dx System	GXXVI-16	FDA UDI	Class II	Active
Xpert MRSA/SA SSTI	GXMRSA/SA-SSTI-10	FDA UDI	Class II	Active
Xpert MTB/RIF	GXMTB/RIF-US-10	FDA UDI	Class II	Active
GeneXpert®	XPRSGBS-10	FDA UDI	Class I	Active
Xpert Xpress Flu	XPRSFLU-10	FDA UDI	Class II	Active
SmartCycler Dx System	SC2500N4-1R	FDA UDI	Class I	Active
Xpert GBS LB	GXGBS-LB-120	FDA UDI	Class I	Active
Xpert Xpress Strep A	XPRSTREPA-120	FDA UDI	Class II	Active
Xpert Factor II & Factor V	GXFIIFV-10	FDA UDI	Class II	Active
GeneXpert Dx System	GXIV-2	FDA UDI	Class II	Unknown
GeneXpert Infinity-80 System	INFINITY 48-32	FDA UDI	Class II	Active
GeneXpert Dx System	GXXVI-12	FDA UDI	Class II	Active
SmartCycler Dx System	SC2500N12-1	FDA UDI	Class I	Active
Xpert C. difficile/Epi	GXCDIFF/EPI-120	FDA UDI	Class I	Active
GeneXpert Dx System	GXIV-3	FDA UDI	Class II	Unknown
GeneXpert Infinity-80 System	INFINITY 80-32	FDA UDI	Class II	Unknown
GeneXpert®	XPRS4PLEX-10	FDA UDI	Class II	Active
Xpert CT/NG	GXCT/NG-10	FDA UDI	Class II	Active
Xpert FLU/RSV XC	GXFLU/RSV-10	FDA UDI	Class II	Active
GeneXpert Dx System	GXIV-3	FDA UDI	Class II	Active
Xpert MRSA NxG	GXMRSA-NXG-10	FDA UDI	Class II	Active
GeneXpert Dx System	GXIV-2	FDA UDI	Class II	Active
GeneXpert Dx System	GXXVI-16	FDA UDI	Class II	Active
GeneXpert Infinity-80 System	INFINITY 80-80	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

Cepheid AB SE
Cepheid Europe S.A.S. FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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