Cytocell
Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of SysmexLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
- Device recalls: 14
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| May 24, 2023 | RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequenClass II · DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. | Device recalls |
| May 24, 2023 | RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequClass II · DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. | Device recalls |
| Oct 27, 2022 | CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782Class II · An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in | Device recalls |
| Oct 27, 2022 | CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probeClass II · Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FI | Device recalls |
| Feb 14, 2022 | Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008Class III · Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. T | Device recalls |
| Feb 4, 2022 | TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Class III · May show unexpected locus specific signals in addition to those at 14q32. | Device recalls |
| Jan 18, 2022 | Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog NumbeClass II · individual components have been labelled with incorrect colours. The red and green colours are opposite to those specifi | Device recalls |
| May 27, 2021 | Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)Class II · May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus spe | Device recalls |
Canada and Imports
Matched by company name- Active Health Canada device licences
- 5, as of Nov 10, 2026
Names and Identifiers
- Appears as
- Website
- cytocell.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built