Device recall: CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in…

Class II FDA enforcement event 88138. Recall start date: 17 May 2021. Status in the FDA record: Terminated. Termination date: 15 Aug 2022.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

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

Cytocell Ltd. started this device recall on 17 May 2021. The firm address in the FDA record is in Cambridge. FDA put the recall in Class II. FDA event 88138 has 1 product record. The first FDA enforcement report date is 4 Aug 2021. The record gives the status Terminated, with the termination date 15 Aug 2022.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.

Recalling firm

Cytocell Ltd., Cambridge, N/A, United Kingdom.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 88138: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2134-2021	CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics	50	Class II	Terminated	4 Aug 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 13

Other events of the firm

Other FDA enforcement events of 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
27 Oct 2022	CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte spe	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
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

Cytocell Ltd.: all 13 events

Official channels

FDA enforcement report Z-2134-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 88138. https://recallregister.com/fda/ii/88138/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.
What quantity of product is in FDA event 88138?: The FDA record gives this quantity: 50
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.