Cytocell Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2829-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 17, 2020

Date Posted: August 26, 2020

Recall Number: Z-2829-2020

Event ID: 86084

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.

Status: Terminated

Product Quantity: 62 units

Code Information:

Lot numbers: 069915, 070433, 069305, 069468

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated