FDA recall Z-2829-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2020-07-17

Report date

2020-08-26

Termination date

2020-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2829-2020