Cytocell Ltd.: Medical Device Recall in 2022 - (Recall #: Z-0341-2023)

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

Product Classification:

Class II

Date Initiated: October 27, 2022

Date Posted: December 7, 2022

Recall Number: Z-0341-2023

Event ID: 91119

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3 units

Code Information:

Lot Number: RD22/230/11

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated