Z-0353-2023 Class II Terminated
FDA device recall Z-0353-2023 was initiated by Cytocell Ltd. on October 27, 2022 and is designated Class II. 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 ve… The recall status is terminated (terminated December 27, 2024).
Recall Details
- Product Type
- Devices
- Report Date
- December 7, 2022
- Initiation Date
- October 27, 2022
- Termination Date
- December 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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
Code Information
Lot RD22/230/10