Cytocell Ltd.

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2209-2023Class IIRET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for deMay 24, 2023
Z-2210-2023Class IIRET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for deteMay 24, 2023
Z-0341-2023Class IICytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782October 27, 2022
Z-0353-2023Class IICytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This devOctober 27, 2022
Z-0824-2022Class IIICytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008February 14, 2022
Z-0814-2022Class IIITCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisFebruary 4, 2022
Z-0741-2022Class IIDel(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location fromJanuary 18, 2022
Z-2323-2021Class IICytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)May 27, 2021
Z-2134-2021Class IICytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte speciMay 17, 2021
Z-1493-2021Class IIChromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPAMarch 19, 2021
Z-1099-2021Class IIAquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelledDecember 22, 2020
Z-2829-2020Class IICytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in greenJuly 17, 2020
Z-1843-2019Class IIIAquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled April 26, 2019
Z-1202-2019Class IIIAquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.March 15, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
DEN170070MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FDecember 21, 2018