Cytocell, Ltd.
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED SRN GB-MF-000016893
Part of Cytocell Limited
- Devices
- 1,961
- Registrations
- EUDAMED
- FDA recalls
- 143 ongoing
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA recalls
What Cytocell, Ltd. makes
Cytocell, Ltd. manufactures assay development analyte-specific reagent in vitro diagnostic devices and genetic mutation probes for acute myeloid leukemia and myelodysplastic syndrome, including products such as CytoCell and CytoCell myProbes.
These devices are classified as Class I and Class II in vitro diagnostics and are listed in the FDA UDI registry; the company is based in the United States.
Catalogue
Search and filter all 1,961 devicesShowing 1-50 of 1,961
Company details
- EUDAMED SRN
- GB-MF-000016893
- EU VAT number
- GB811985417
- EUDAMED status
- Active
- EUDAMED registered name
- Cytocell Limited
- EUDAMED abbreviated name
- Cytocell Ltd
- Registered address
- Oxford Gene Technology, 418 Cambridge Science Park, CB4 0PZ, CAMBRIDGE, United Kingdom (ex Northern Ireland)
- contact@ogt.com
- Phone
- +44 (0)1223 294048
- PRRC contact
- Anthony Gore
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 8 Mar 2028
BSI Group The Netherlands B.V. 2797 1 certificate
- IVDR 747622 Active
Quality management system EU IVDR
- Issued
- 23 Jul 2026
- Expires
- 8 Mar 2028
- Reason
- Change approved
FDA recalls
FDA recall records list 14 recalls initiated by Cytocell, Ltd., the earliest on 2019-03-15 and the most recent on 2023-05-24. By recorded status: 3 ongoing and 11 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, 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 0
- 2018 0
- 2019 2
- 2020 2
- 2021 3
- 2022 5
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 24 May 2023 Z-2209-2023 Class II Ongoing DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
- 24 May 2023 Z-2210-2023 Class II Ongoing DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
2022
- 27 Oct 2022 Z-0341-2023 Class II Terminated An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
- 27 Oct 2022 Z-0353-2023 Class II Terminated Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert
- 14 Feb 2022 Z-0824-2022 Class III Terminated Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.
- 4 Feb 2022 Z-0814-2022 Class III Terminated May show unexpected locus specific signals in addition to those at 14q32.
- 18 Jan 2022 Z-0741-2022 Class II Terminated individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
2021
- 27 May 2021 Z-2323-2021 Class II Terminated May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
- 17 May 2021 Z-2134-2021 Class II Terminated The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
- 19 Mar 2021 Z-1493-2021 Class II Ongoing Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Show all 14 recalls
2020
- 22 Dec 2020 Z-1099-2021 Class II Terminated Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.
Full distribution text
- 17 Jul 2020 Z-2829-2020 Class II Terminated A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
- 22 Dec 2020 Z-1099-2021 Class II Terminated Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.
2019
- 26 Apr 2019 Z-1843-2019 Class III Terminated There is an error in the chromomap on the package insert.
Full distribution text
- 15 Mar 2019 Z-1202-2019 Class III Terminated There is an error in the chromomap included in the labeling for the product.
- 26 Apr 2019 Z-1843-2019 Class III Terminated There is an error in the chromomap on the package insert.
Frequently asked questions
How many devices does Cytocell, Ltd. have in the registry?
The registry currently lists 1961 devices for Cytocell, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cytocell, Ltd.'s devices?
Among its 50 most recently registered devices, Cytocell, Ltd. has devices listed in EUDAMED (10 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cytocell, Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Cytocell, Ltd.'s devices are Class I and IVDR Class C. Each device page shows its own class and authorisation.
Are there FDA recall records for Cytocell, Ltd.?
FDA recall records list 14 recalls initiated by Cytocell, Ltd., the most recent initiated on 24 May 2023. 3 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 EUDAMED certificates are recorded for Cytocell, Ltd.?
EUDAMED lists 1 certificate for Cytocell, Ltd. (quality management system) under IVDR. The most recent was issued on 23 Jul 2026.
What are the newest devices from Cytocell, Ltd. in the registry?
The most recently registered devices listed for Cytocell, Ltd. include IGH/MYEOV Plus Translocation, Dual Fusion Probe, IGH/FGFR3 Plus Translocation, Dual Fusion Probe, IGH Plus Breakapart Probe and FAST FISH Prenatal Enumeration Probe kit.