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Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
Recalled January 12, 2022 · FDA recall Z-0463-2022 · Abbott Molecular
Hazard
There is an issue with the installation of updated camera firmware on the system. · FDA Class II
Units
74 devices
Sold at
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
Description
There is an issue with the installation of updated camera firmware on the system.
Product
Alinity m System, Part No. 08N53-002
Manufacturer(s)
Abbott Molecular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →