FDA recall Z-2576-2021

Abbott Molecular, Inc. · Class II · device

Product

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes

Reason for recall

Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MI, MN, MA, NC, NJ, NM, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and the countries of Australia, Belgium, Brazil, Canada, China, Costa Rica, Czech Republic, Estonia, Germany, Hong Kong, Israel, Italy, Kazakhstan, Netherlands, Philippines, Poland, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, United Kingdom, Uruguay.

Key facts

Status: Terminated
Initiation date: 2021-08-04
Report date: 2021-10-06
Termination date: 2023-05-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2576-2021