FDA recall Z-0353-2023

Product

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

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

Distribution

TX

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-0353-2023