Home / Recalls / Cytocell Ltd. / Z-0353-2023

Z-0353-2023 Class II Terminated

Recalled by Cytocell Ltd. — Cambridge

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

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  • Z-0341-2023 Class II — CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD (October 27, 2022)
  • Z-0824-2022 Class III — Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 (February 14, 2022)
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  • Z-0741-2022 Class II — Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chro (January 18, 2022)
  • Z-2323-2021 Class II — Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte speci (May 27, 2021)
  • Z-2134-2021 Class II — CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU0 (May 17, 2021)
  • Z-1493-2021 Class II — Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific (March 19, 2021)
  • Z-1099-2021 Class II — Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Di (December 22, 2020)