Cytocell Ltd. recalls RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locatin…

Recall date

May 24, 2023

Source

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

Recall number

Z-2209-2023

FDA classification

Class II

Brand / firm

Cytocell Ltd.

Sold / distributed

US Nationwide distribution in the states of CA, FL, OH, & SC.

Why it was recalled

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

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

What was recalled

RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.