FDA-Device2021-08-18Class II
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Abbott Laboratories, Inc
Hazard
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Sold states
Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.
Affected count
260 systems
Manufactured in
1921 Hurd Dr, N/A, Irving, TX, United States
Products
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2276-2021Don't want to check this manually?
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