Cytocell product recalled over labeling errors

Recall date

October 27, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cytocell Ltd. recalls CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte sp…

Recall number

Z-0353-2023

FDA classification

Class II

Brand / firm

Cytocell Ltd.

Sold / distributed

TX

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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