Cytocell Ltd. recalls Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151…

Recall date

July 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2829-2020

FDA classification

Class II

Brand / firm

Cytocell Ltd.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.