FDA recall Z-1493-2021

Cytocell Ltd. · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2021-03-19
Report date
2021-05-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1493-2021