CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This ...

FDA Device Recall #Z-0353-2023 — Class II — October 27, 2022

Recall Summary

Recall Number Z-0353-2023
Classification Class II — Moderate risk
Date Initiated October 27, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cytocell Ltd.
Location Cambridge
Product Type Devices

Product Description

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 Pattern

TX

Lot / Code Information

Lot RD22/230/10

Other Recalls from Cytocell Ltd.

Recall # Classification Product Date
Z-2210-2023 Class II RET Distal Probe. Used in Fluorescence in situ ... May 24, 2023
Z-2209-2023 Class II RET Proximal Probe. Used in Fluorescence in sit... May 24, 2023
Z-0341-2023 Class II CytoCell BCL11B Distal in Texas Red Spectrum- A... Oct 27, 2022
Z-0824-2022 Class III Cytocell 8 Square Template Slides (Glass)- micr... Feb 14, 2022
Z-0814-2022 Class III TCL1 Breakapart Probe, Fluorescence in situ hyb... Feb 4, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.