FDA Device recall Z-0353-2023
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy
- FDA Device
- Class II
- terminated
- Published 2022-12-07
On 2022-12-07 the FDA classified a Class II recall of CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy by Cytocell, citing 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 devic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0353-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-27 |
| Published | 2022-12-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cytocell |
| Distribution | TX |
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
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
Identifiers
| code_info | Lot RD22/230/10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0353-2023%22
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