--- title: "Cytocell Ltd. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Cytocell Ltd. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/cytocell-ltd/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Cytocell Ltd. recall records **2** reported ongoing 7 records in this archive. Latest source date May 24, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 24, 2023 FDA device enforcement ### [RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.](https://isitonrecall.com/recall/fda-device-z-2209-2023-ret-proximal-probe-used-in-fluorescence-in-situ-hybridization-fish-a-laboratory-technique-for-detect/) DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, FL, OH, & SC. [Official source for RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2209-2023%22) May 24, 2023 FDA device enforcement ### [RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.](https://isitonrecall.com/recall/fda-device-z-2210-2023-ret-distal-probe-used-in-fluorescence-in-situ-hybridization-fish-a-laboratory-technique-for-detectin/) DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, FL, OH, & SC. [Official source for RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for d...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2210-2023%22) Oct 27, 2022 FDA device enforcement ### [CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782](https://isitonrecall.com/recall/fda-device-z-0341-2023-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. Class II Reported terminated Distribution: TX [Official source for CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0341-2023%22) Oct 27, 2022 FDA device enforcement ### [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 t...](https://isitonrecall.com/recall/fda-device-z-0353-2023-cytocell-bcl11b-proximal-in-fitc-spectrum-ldt-for-investigation-t-cell-related-malignancy-this-devic/) 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 no... Class II Reported terminated Distribution: TX [Official source for CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This d...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0353-2023%22) Feb 14, 2022 FDA device enforcement ### [Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008](https://isitonrecall.com/recall/fda-device-z-0824-2022-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. Class III Reported terminated Distribution: US Nationwide distribution in the states of CT, TX. [Official source for Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0824-2022%22) Feb 4, 2022 FDA device enforcement ### [TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A](https://isitonrecall.com/recall/fda-device-z-0814-2022-tcl1-breakapart-probe-fluorescence-in-situ-hybridisation-fish-is-a-technique-allows-the-visualisatio/) May show unexpected locus specific signals in addition to those at 14q32. Class III Reported terminated Distribution: MN [Official source for TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visual...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0814-2022%22) Jan 18, 2022 FDA device enforcement ### [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](https://isitonrecall.com/recall/fda-device-z-0741-2022-del-5q-deletion-fish-probe-kit-in-vitro-diagnostic-to-detect-deletions-in-chromosome-location-from-p/) 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.... Class II Reported terminated Distribution: US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee. [Official source for Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location f...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0741-2022%22) ## Reasons in these listed records - DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. - 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. - 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 de... - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Cytocell Ltd. ### Is there a recall on cytocell ltd. right now? This archive contains 7 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Cytocell Ltd.](https://isitonrecall.com/check/?q=Cytocell%20Ltd.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)