Cytocell Ltd.: Medical Device Recall in 2022 - (Recall #: Z-0353-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 27, 2022

Date Posted: December 7, 2022

Recall Number: Z-0353-2023

Event ID: 91117

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

Status: Terminated

Product Quantity:

Code Information:

Lot RD22/230/10

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated