Device recall: CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte spe

FDA enforcement event 91117 · Class II · initiated 27 Oct 2022 · status Terminated · terminated 27 Dec 2024

DeviceVoluntary: Firm initiated1 product record

Cytocell Ltd. (Cambridge) initiated this device recall on 27 Oct 2022; FDA lists 1 product record under event 91117, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 27 Dec 2024. Initiation: voluntary: firm initiated. Cytocell Ltd. has 13 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Cytocell Ltd., Cambridge, United Kingdom.

Reason for recall

"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"

Distribution

"TX"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0353-2023	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	—	Class II	Terminated	7 Dec 2022

Context

88%of 2022 device events are Class II839 events that year

1product record in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for Cytocell Ltd.

Initiated	Product (first record)	Type	Class	Records
24 May 2023	RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating	Device	Class II	2
27 Oct 2022	CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782	Device	Class II	1
14 Feb 2022	Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008	Device	Class III	1
4 Feb 2022	TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequence	Device	Class III	1
18 Jan 2022	Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML o	Device	Class II	1
27 May 2021	Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)	Device	Class II	1
17 May 2021	CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vi	Device	Class II	1
19 Mar 2021	Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481	Device	Class II	1
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	Device	Class II	1
17 Jul 2020	Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151k	Device	Class II	1

All 13 events for Cytocell Ltd.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "TX"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 27 Dec 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.