Lower risk Medical device recall · FDA · Published October 27, 2022

Cytocell BCL11B Proximal Probe Mislabeling Risk

Cytocell recalls a T-cell malignancy test probe due to incorrect chromomap in package inserts. This may affect lab results but does not pose immediate safety risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0353-2023Medical device Cytoc: a company name from the title ›

Lower-risk 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

Take action

Contact the company

Recalling firmCytocell Ltd.418 Cambridge Science Park, Milton Road, Oxford Gene Technology · Cambridge, United Kingdom

✎ GovInfoNow plain-language explainer

Cytocell is recalling a specific lab test probe for T-cell related malignancy because its package insert contains an incorrect chromomap. This could lead to inaccurate lab results but does not pose a direct safety risk to users. Read more at govinfonow.com/recall/59803-cytocell-bcl11b-proximal-probe-mislabeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/59803-cytocell-bcl11b-proximal-probe-mislabeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0353-2023

Cite this page

“Cytocell BCL11B Proximal Probe Mislabeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59803-cytocell-bcl11b-proximal-probe-mislabeling-risk. Based on FDA recall #Z-0353-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0353-2023%22&limit=1).

Cytocell Ltd. recalled the CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation of T-cell related malignancy due to a mislabeled package insert, according to the FDA. The Food and Drug Administration announced the Class II recall on Oct. 27, 2022.

How to tell if you have it

Brand: Cytocell
Product: CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy
Ref: MPD39781
Lot: RD22/230/10
Distribution: TX

The hazard

The package insert for this analyte specific reagent probe contains an incorrect chromomap that does not match the probe design or specification. The image showing the position the FISH probe maps to on the specific chromosome is erroneous in version 1 of the insert.

Context

GovInfoNow's records show Cytocell Ltd. has 12 other recalls on record since March 15, 2019. Other recent recalls of similar products include HydroMARK Breast Biopsy Marker Recall (April 24, 2026) and Hologic ThinPrep CytoLyt Solution Recall (Dec. 12, 2025).

How to tell if you have this one

Check for the model reference MPD39781 on the package or label. The product was sold with lot number RD22/230/10.

Brand
Cytoc: a company name from the title
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Package Details
Look for the model reference MPD39781 and lot number RD22/230/10 on the product label.

Where it went and when

Where it was distributed

Distributed in Texas.

FDA distribution: “TX” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Texas.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Oct 27, 2022Firm started the recall
Dec 1, 2022FDA classified it Class II
Dec 7, 2022Published in FDA’s Enforcement Report
Dec 27, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/59803-cytocell-bcl11b-proximal-probe-mislabeling-risk">Cytocell BCL11B Proximal Probe Mislabeling Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0353-2023 (October 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0353-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.