FDA-Device2022-01-12Class II
Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc.
Hazard
There is an issue with the installation of updated camera firmware on the system.
Sold states
Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam
Affected count
74 devices
Manufactured in
1300 E Touhy Ave, N/A, Des Plaines, IL, United States
Products
Alinity m System, Part No. 08N53-002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0463-2022Don't want to check this manually?
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