Cytocell Ltd. recalls Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481

Recall date

March 19, 2021

Source

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

Recall number

Z-1493-2021

FDA classification

Class II

Brand / firm

Cytocell Ltd.

Sold / distributed

US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.

Why it was recalled

Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.

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

What was recalled

Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481