Cepheid
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000010979 FEI 3016838963
Cepheid is a medical device manufacturer based in the United States, with 228 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I; EU IVD General and Class A) and 19 FDA recalls as of 13 Nov 2026.
- Devices
- 228
- Registrations
- EUDAMEDFDA
- FDA recalls
- 197 ongoing
Registry facts
- Registries
- FDA GUDID 144
- FDA 510(k) 64
- EUDAMED 32
- Device classes
- FDA Class II 163
- FDA Class I 34
- EU IVD General 18
- EU Class A 12
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Cepheid AB authorised representative
- Cepheid Europe S.A.S. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000010979
- FDA FEI 3016838963
- DUNS 956711444
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment, FDA recalls
- Authorised rep.
- Cepheid ABSE
- Authorised rep.
- Cepheid Europe S.A.S.FR
What Cepheid makes
The company manufactures laboratory-based thermal cyclers and nucleic acid amplification analysers for in vitro diagnostics, alongside single-use swabs and applicators. Their product portfolio includes kits for detecting Group B Streptococcus, methicillin-resistant *Staphylococcus aureus* (MRSA), *Clostridium difficile*, and inherited thrombophilia via nucleic acid techniques. Sample preparation instruments and rapid diagnostic assays for respiratory pathogens, such as *Streptococcus* and *Chlamydia trachomatis*/*Neisseria gonorrhoeae*, are also produced. Inherited coagulation disorders and *Bacillus cereus* enterotoxin are among other targets addressed by their nucleic acid-based tests.
These devices are regulated under EU IVD General, FDA Class I, and Class II classifications, with listings in the EUDAMED registry, FDA’s 510(k) database, and FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.
Catalogue
Search and filter all 228 devicesShowing 1-50 of 228
Company details
- EUDAMED SRN
- US-MF-000010979
- FDA FEI number
- 3016838963
- DUNS number
- 956711444
- EUDAMED status
- Active
- EUDAMED registered name
- Cepheid
- Registered address
- 904, Caribbean Drive, 94089, Sunnyvale, CA, United States
- Website
- WWW.CEPHEIDINTERNATIONAL.COM
- Phone
- 18888383222
- PRRC contact
- Aarthi Raman
FDA recalls
FDA recall records list 19 recalls initiated by CEPHEID, the earliest on 2005-07-22 and the most recent on 2025-11-05. By recorded status: 7 ongoing and 12 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 2
- 2024 1
- 2025 4
- 2026 0
2025
- 5 Nov 2025 Z-0724-2026 Class II Ongoing Product testing did not meet expected stability criteria.
- 30 Oct 2025 Z-0959-2026 Class II Ongoing Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Full distribution text
- 30 Oct 2025 Z-0960-2026 Class II Ongoing Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Full distribution text
- 6 Aug 2025 Z-0414-2026 Class II Ongoing As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Full distribution text
2024
- 20 Jun 2024 Z-2584-2024 Class II Ongoing 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.
Full distribution text
- 20 Jun 2024 Z-2584-2024 Class II Ongoing 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.
2023
- 24 Apr 2023 Z-0215-2024 Class II Ongoing 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.
Full distribution text
- 24 Apr 2023 Z-0216-2024 Class II Ongoing 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.
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- 24 Apr 2023 Z-0215-2024 Class II Ongoing 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.
2017
- 9 Oct 2017 Z-0592-2018 Class II 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.
- 15 Sep 2017 Z-0028-2018 Class II Terminated Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Full distribution text
2016
- 18 Jul 2016 Z-2548-2016 Class II Terminated Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Show all 19 recalls
2015
- 27 Jul 2015 Z-2431-2015 Class III 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.
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- 27 Jul 2015 Z-2432-2015 Class III 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.
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- 27 Jul 2015 Z-2431-2015 Class III 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.
2011
- 17 Nov 2011 Z-0453-2012 Unclassified (pre-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.
- 1 Apr 2011 Z-2401-2011 Unclassified (pre-2012) 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.
Full distribution text
2010
- 5 Apr 2010 Z-1898-2010 Unclassified (pre-2012) Terminated The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.
- 19 Feb 2010 Z-1651-2010 Unclassified (pre-2012) 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.
- 19 Feb 2010 Z-1652-2010 Unclassified (pre-2012) 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.
2007
- 5 Sep 2007 Z-0376-2008 Unclassified (pre-2012) 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)
2005
- 22 Jul 2005 Z-1378-05 Unclassified (pre-2012) Terminated A problem in the software has the potential to be associated with the incorrect reporting of sample results.
Full distribution text
- 22 Jul 2005 Z-1378-05 Unclassified (pre-2012) Terminated A problem in the software has the potential to be associated with the incorrect reporting of sample results.
FDA establishments
- Cepheid AB SOLNA Stockholm · SE FEI 3009613136
Frequently asked questions
How many devices does CEPHEID have in the registry?
The registry currently lists 228 devices for CEPHEID. Devices recorded under merged duplicate company entries are counted once.
Which registries list CEPHEID's devices?
Among its 50 most recently registered devices, CEPHEID has devices listed in EUDAMED (19 devices), FDA 510(k) (4 devices) and FDA GUDID (27 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CEPHEID's devices fall under?
Among its 50 most recently registered devices, the classes recorded for CEPHEID's devices are Class I, Class II, IVDR Class A and IVD general. Each device page shows its own class and authorisation.
Are there FDA recall records for CEPHEID?
FDA recall records list 19 recalls initiated by CEPHEID, the most recent initiated on 5 Nov 2025. 7 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from CEPHEID in the registry?
The most recently registered devices listed for CEPHEID include Xpert® XPRSCOV2/FLU-10, Xpert®, Xpert® GXRESP-10 and GeneXpert® GX4.
Which FDA establishments are linked to CEPHEID?
1 FDA establishment is linked to CEPHEID in the registry; they are listed on the company page.