Home / Recalls / Medical Devices
Abbott Laboratories, Inc recalls Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening,
Recalled August 18, 2021 · FDA recall Z-2276-2021 · Abbott Laboratories
Hazard
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators. · FDA Class II
Units
260 systems
Sold at
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.
Description
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Product
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.
Manufacturer(s)
Abbott Laboratories, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →