Home / Recalls / Cytocell Ltd. / Z-2829-2020

Z-2829-2020 Class II Terminated

Recalled by Cytocell Ltd. — Cambridge, N/A

Recall Details

Product Type
Devices
Report Date
August 26, 2020
Initiation Date
July 17, 2020
Termination Date
September 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
62 units

Product Description

Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.

Reason for Recall

A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the country of Canada.

Code Information

Lot numbers: 069915, 070433, 069305, 069468

Other recalls by Cytocell Ltd.

  • Z-2209-2023 Class II — RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laborat (May 24, 2023)
  • Z-2210-2023 Class II — RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laborator (May 24, 2023)
  • Z-0341-2023 Class II — CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD (October 27, 2022)
  • Z-0353-2023 Class II — CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related m (October 27, 2022)
  • Z-0824-2022 Class III — Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 (February 14, 2022)
  • Z-0814-2022 Class III — TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique (February 4, 2022)
  • 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)