Cytocell recalls BCL11B Distal in Texas Red Spectrum reagent due to incorrect chromomap coordinates in version 1 package inserts. Affected units may have inaccurate nucleotide locations.
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.
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 reagent product because its version 1 package insert contains incorrect chromomap coordinates. This error means the nucleotide locations listed are technically correct but the map uses wrong coordinates, which could lead to misinterpretation of results. Read more at govinfonow.com/recall/59802-cytoc-bcl11b-reagent-recall-incorrect-chromomap-coordinates.
“Cytoc: BCL11B Reagent Recall - Incorrect Chromomap Coordinates.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59802-cytoc-bcl11b-reagent-recall-incorrect-chromomap-coordinates. Based on FDA recall #Z-0341-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0341-2023%22&limit=1).
The FDA announced on 2022-10-27 that Cytocell Ltd. voluntarily recalled CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent due to an incorrect chromomap in the package insert. The error involves wrong coordinates for nucleotide locations.
How to tell if you have it
Brand: Cytocell
Product: CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent
Ref: MPD39782
Lot Number: RD22/230/11
Distribution: TX
The hazard
The package insert for version 1 of the product contains a chromomap created using wrong coordinates. While the specified nucleotide locations are correct, the map itself is incorrect.
Context
GovInfoNow's records show Cytocell Ltd. has 12 other recalls on record since 2019-03-15. Other recent recalls of similar products include Cytocell RET Proximal Probe Recall (2023-05-24), Cytocell BCL11B Proximal Probe Mislabeling Risk (2022-10-27), and Cytocell 8 Square Template Slides Recall (2022-02-14). Other recent recalls of similar products include HydroMARK Breast Biopsy Marker Recall (2026-04-24).
How to tell if you have this one
Check for the product name 'CytoCell BCL11B Distal in Texas Red Spectrum' and lot number RD22/230/11 on the reagent packaging. The affected version is version 1 of the package insert.
Brand
Cytocell
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Package Insert Version
Verify the package insert version is 1, as this version contains the incorrect chromomap coordinates.
Where it went and when
Where it was distributed
Distributed in Texas.
Listed by the agency
Not listed
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.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
No, you can continue using the reagent but you should check the package insert version. If it's version 1, you may want to contact Cytocell for updated instructions.
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-0341-2023 (October 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0341-2023 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.