FDA-Device2022-01-12Class II
Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc.
Hazard
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Sold states
Worldwide distribution - US distribution 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-0462-2022Don't want to check this manually?
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