Cytocell Ltd. recalls Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML…

Recall date

January 18, 2022

Source

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

Recall number

Z-0741-2022

FDA classification

Class II

Brand / firm

Cytocell Ltd.

Sold / distributed

US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.

Why it was recalled

individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result

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

What was recalled

Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024