Cytocell Ltd. recalls CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

Recall date

October 27, 2022

Source

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

Recall number

Z-0341-2023

FDA classification

Class II

Brand / firm

Cytocell Ltd.

Sold / distributed

TX

Why it was recalled

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.

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 Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782