Cytocell Ltd.

FDA recalling firm · 13 enforcement events · 14 product records · 2019–2023 · N/A

Cytocell Ltd. has 13 FDA enforcement events on this register (14 product records) between 2019 and 2023: 13 device; the busiest year was 2022 with 5.

0% of its events are Class I; the most common class is Class II (9). 2 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
24 May 2023	RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.	Device	Class II	2	Ongoing
27 Oct 2022	CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782	Device	Class II	1	Terminated
27 Oct 2022	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: MPD39781	Device	Class II	1	Terminated
14 Feb 2022	Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008	Device	Class III	1	Terminated
4 Feb 2022	TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A	Device	Class III	1	Terminated
18 Jan 2022	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	Device	Class II	1	Terminated
27 May 2021	Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)	Device	Class II	1	Terminated
17 May 2021	CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics	Device	Class II	1	Terminated
19 Mar 2021	Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481	Device	Class II	1	Ongoing
22 Dec 2020	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	Device	Class II	1	Terminated
17 Jul 2020	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 situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon…	Device	Class II	1	Terminated
26 Apr 2019	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. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13…	Device	Class III	1	Terminated
15 Mar 2019	Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.	Device	Class III	1	Terminated

By type and class

Device13

Class II9

Class III4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Cytocell Ltd. by year initiated.

Questions and answers

How many FDA recalls has Cytocell Ltd. had?

13 enforcement events (14 product records) on this register, 2019–2023: 13 device.

Are any Cytocell Ltd. recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Cytocell Ltd. recalls?

9 Class II, 4 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.