FDA recall Z-0341-2023

Cytocell Ltd. · Class II · device

Product

CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

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.

Distribution

Key facts

Status: Terminated
Initiation date: 2022-10-27
Report date: 2022-12-07
Termination date: 2024-12-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0341-2023