Data / Medical devices / United Kingdom / Cytocell Limited
Cytocell Limited: FDA-registered device maker in CAMBRIDGE Cambridgeshire, United Kingdom, 2 510(k) clearances
Cytocell Limited is registered with the FDA (registration 9710378) in CAMBRIDGE Cambridgeshire, United Kingdom. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 19, 2025. 13 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710378
- FEI number
- 3002646096
- Address
- Oxford Gene Technology 418 Cambridge Science Park, Milton Road, CAMBRIDGE Cambridgeshire, United Kingdom, CB4 0PZ
- Owner or operator
- Oxford Gene Technology (IP) Limited (9026291)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- June 14, 2001
- Registered through
- 2026
- Brand names listed
- Analyte Specific Reagents with the following brand names:, CytoCell, CytoCell 20x SSC Buffer (PCA 003), CytoCell 24 Square Template Slides (PCN 007), CytoCell 8 Square Template Slides (PCN 008), CytoCell DAPI Antifade Counterstain ES (DES 500L, DES 1000L, DES 10ML), CytoCell DAPI Antifade Counterstain FS (DFS 500L, DFS 10ML), CytoCell DAPI Antifade Counterstain SS (DSS 500L) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies | QDI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Revumenib Eligibility Detection System | SFS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 19, 2025 | DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | SFS | Unknown | Cytocell Limited | accessdata.fda.gov |
| December 21, 2018 | DEN170070 | MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit | QDI | Unknown | Cytocell, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 24, 2023 | 92586 | Class II | Ongoing | RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome. | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. | accessdata.fda.gov |
| October 27, 2022 | 91119 | Class II | Terminated | CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782 | 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. | accessdata.fda.gov |
| October 27, 2022 | 91117 | Class II | Terminated | CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MP | 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 | accessdata.fda.gov |
| February 14, 2022 | 89747 | Class III | Terminated | Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 | 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. | accessdata.fda.gov |
| February 4, 2022 | 89669 | Class III | Terminated | TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A | May show unexpected locus specific signals in addition to those at 14q32. | accessdata.fda.gov |
| January 18, 2022 | 89602 | Class II | Terminated | Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024 | 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 inc | accessdata.fda.gov |
| May 27, 2021 | 88294 | Class II | Terminated | Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's) | May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34 | accessdata.fda.gov |
| May 17, 2021 | 88138 | Class II | Terminated | CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics | 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. | accessdata.fda.gov |
| March 19, 2021 | 87621 | Class II | Ongoing | Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481 | Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34. | accessdata.fda.gov |
| December 22, 2020 | 87090 | Class II | Terminated | Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene | 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. | accessdata.fda.gov |
| July 17, 2020 | 86084 | Class II | Terminated | Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in | 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. | accessdata.fda.gov |
| April 26, 2019 | 82917 | Class III | Terminated | Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. | There is an error in the chromomap on the package insert. | accessdata.fda.gov |
| March 15, 2019 | 82599 | Class III | Terminated | Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent. | There is an error in the chromomap included in the labeling for the product. | accessdata.fda.gov |
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Updated September 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.