FDA-Device2015-11-04Class II
ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
Abbott Laboratories, Inc
Hazard
Incorrect tubing.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan
Affected count
65 units
Manufactured in
1921 Hurd Dr, N/A, Irving, TX, United States
Products
ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2016Don't want to check this manually?
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