Z-0353-2023Class II

CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an...

Name: Z-0353-2023 CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an...
Creator: Cytocell Ltd.
Published: 2022-10-27
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2022-10-27 / Terminated / root cause: labeling and UDI

FDA source

Cytocell Ltd. began a recall of CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the... on 2022-10-27. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0353-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-27
Posted: 2022-12-01
Terminated: 2024-12-27
Recalling firm: Cytocell Limited
Product: 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
Product code: MVU Reagents, Specific, Analyte
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
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Cytocell issued Urgent Medical Device Recall letter on 10/27/22 to the end-user via email. Letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert. Once implemented, all devices can continue to be used as the device itself has not malfunctioned. Please complete and return the enclosed response form as soon as possible. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].
Distribution: TX
Product codes and lots: Lot RD22/230/10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0353-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0353-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-07	2022-12-01

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)