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
- Recall Initiated
- October 27, 2022
- Posted
- December 1, 2022
- Terminated
- December 27, 2024
- Recall Number
- Z-0353-2023
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
Lot / Code Info
Lot RD22/230/10
Root Cause
Under Investigation by firm
Action Taken
Cytocell issued Urgent Medical Device Recall letter on 10/27/22 to the end-user via email. Letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert. Once implemented, all devices can continue to be used as the device itself has not malfunctioned. Please complete and return the enclosed response form as soon as possible. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com.