Cytocell Ltd. recalls CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in v…

Recall date

May 17, 2021

Source

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

Recall number

Z-2134-2021

FDA classification

Class II

Brand / firm

Cytocell Ltd.

Sold / distributed

Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.

Why it was recalled

The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.

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 DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics