FDA-Device2023-04-05Class II
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
Instrumentation Laboratory
Hazard
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China, Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico, Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.
Affected count
129 units US; 2686 units OUS
Manufactured in
180 Hartwell Rd, N/A, Bedford, MA, United States
Products
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1305-2023Don't want to check this manually?
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