FDA-Device2022-01-12Class II
Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc.
Hazard
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.
Affected count
742 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-0461-2022Don't want to check this manually?
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